Clinical trials are a means of developing new medicines, devices or procedures for the purpose of gaining medical knowledge relevant to the prevention, detection, diagnosis, control, and treatment of medical diseases and conditions. More specifically, clinical trials are scientific studies designed to evaluate one or more groups of subjects, using one or more types of interventions. The predominant intervention studied in clinical research is medicine. Consequently, experimental drugs are the focus of this website.
- Learn about the phases throughout a clinical trial: download pdf.
- Learn about the terminology commonly used in clinical trials: download pdf.
- View a list of individuals involved in UC clinical trials: click here.
Current Clinical Trials
Click on the clinical trial category to jump directly to all clinical trials pertaining to the category:
General Clinical Trials
Topic: Bone Mets
Title: S0702, A Prospective Observational Multicenter Cohort Study to Assess The Incidence of Osteonecrosis of the Jaw (ONJ) in Cancer Patients with Bone Metastases Starting Zoledronic Acid Treatment
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This clinical trial is studying osteonecrosis of the jaw in patients with cancer who are receiving zoledronic acid for bone metastases.
Gathering information about how often osteonecrosis of the jaw occurs in patients receiving zoledronic acid for bone metastases may help doctors learn more about the disease and provide the best follow-up care. Patients undergo dental assessments at baseline and every 3-6 months for 3 years
A total of 7200 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have cancer that has spread to the bone and are currently receiving or are planning to receive zoledronic acid as a part of their treatment.a
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
Brain Cancer Clinical Trials
Topic: Newly Diagnosed Glioblastoma
Title: RTOG S0825, Phase III Double-Blind Placebo Controlled Trial of Conventional Concurrent Chemoradiation and Adjuvant Temozolomide Plus Bevacizumab versus Conventional Concurrent Chemoradiation and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma
Trial Dates: Ongoing
Place: The Barrett Center; The Medical Arts Building; University Pointe; VA Medical Center
Overview: Glioblastoma is a brain tumor. This study is for patients who have been recently diagnosed with such a tumor. A recent study has demonstrated that combining temozolomide with radiation and following this treatment with temozolomide treatment improved tumor control compared to radiation alone. This is now the standard of care. Bevacizumab is being added in this study due to information that demonstrates it may interrupt the body's ability to grow new blood vessels, causing tumors to shrink. In addition, this study will try to determine whether the response to Bevacizumab and the overall outcome depend on a genetic pattern in the tumor.
Eligible patients are placed into a treatment group by chance (randomized) Half of the patients with be treated with traditional treatment, the other half of patients will be treated with the investigational treatment being studied (Beyacizumab).
After completion of study treatment, the study doctor will ask you visit the clinic every three (3) months for the first year, then every four (4) months for the second year and then every six (6) months for the rest of your life.
About five (5) people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately seven hundred twenty (720) people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 and have been diagnosed with a brain tumor that is glioblastoma
How to sign up: Please contact U.C. Cancer Center with any questions, (513) 584-7698 or (888) 724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Brain Tumor
Title: A Phase I/II Trial for Patients with Recurrent, Resectable Glioblastoma Multiforma Using Surgery with Implantable BCNU Polymer Followed by Post-operative Irinotecan and Bevacizumab
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe
Overview: The purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patient with recurrent Glioblastoma Multiforme (GBM) brain tumor that can be removed by brain surgery. This study will find out what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where your tumor was during your surgery and post-operative chemotherapy has on you and your survival rate over the next 12 months. Patients undergo surgery to remove the tumor and insertion of the chemotherapy wafers. This treatment is considered standard of care. Approximately 5 weeks after your surgery, you will be treated with Avastin and Irinotecan. These medications are given by IV once every 2 weeks. Avastin and Irinotecan are FDA approved treatments for colon and lung cancer, but are not currently FDA approved for brain tumors. Your treatments will stop if your cancer continues to grow, you have severe side effects, or you have completed 12 months of treatment.
Qualifications: Eligible patients must be at least 18 years old and have recurrent, respectable glioblastoma multiforme. Patients that have already had surgery are eligible candidates if Gliadel wafers were inserted at the time of the surgery, and post-operative chemotherapy will be able to start within 5 week of the surgery.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Brain cancer
Title: RTOG 0627, Phase II Trial of Dasatinib in Patients With Recurrent Glioblastoma Multiforme
Trial Dates: Ongoing
Place: The Barrett Center, The Medical Arts Building, University Pointe, VA Medical Center
Overview: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This phase II trial is studying how well dasatinib works in treating patients with recurrent glioblastoma multiforme or gliosarcoma.
Eligible patients receive oral dasatinib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Tumor biopsies are collected at baseline and after the completion of study treatment. Immunohistochemistry and western blot analysis of baseline tissue are performed to identify molecular signatures that predict glioblastoma sensitivity to dasatinib. The presence of the targets (SRC, platelet-derived growth factor receptor [PDGFR] beta, EPHA2, and KIT) and their activated (phosphorylated) forms are examined and correlated with clinical outcome. Specimens are also examined for mutations that increase dasatinib sensitivity.
After the completion of study treatment, patients are followed periodically.
About 15 people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 83 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age and have a glioblastoma, a type of brain tumor that has grown following treatment with radiation and the drug temozolomide.
How to sign up: Please contact U.C. Cancer Center with any questions, (513) 584-7698 or (888) 724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Brain Cancer
Title: R0614, A Randomized, Phase III, Double-Blind, Placebo-Controlled Trial of Memantine for Prevention of Cognitive Dysfunction in Patients Receiving Whole-Brain Radiotherapy
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: Memantine may be able to decrease side effects caused by whole-brain radiation therapy. It is not yet known if memantine is effective in preventing side effects caused by whole-brain radiation therapy. This randomized phase III trial is studying memantine to see how well it works compared to a placebo in preventing side effects caused by whole-brain radiation therapy in patients with brain metastases from solid tumors.
Patients in Arm 1 undergo whole-brain radiotherapy (WBRT) 5 days a week for 3 weeks (15 fractions). Patients also receive oral memantine hydrochloride once daily beginning on day 1 of WBRT and continuing for 24 weeks. Patients in Arm 2 undergo WBRT as in arm 1. Patients also receive oral placebo once daily beginning on day 1 of WBRT and continuing for 24 weeks.
After patients are finished taking memantine or placebo, the study doctor will ask the patient to visit the office for follow up exams at one year, every four months the following year, then every 6 months for the next two years, and then annually as long as the patient lives.
Qualifications: Eligible patients must be at least 18 years old and have cancer that has spread to the brain.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
Breast Cancer Clinical Trials
Topic: Breast Cancer
Title: MAP.3 A Phase III Randomized Study of Exemestane Versus Placebo in Women at an Increased Risk of Developing Breast Cancer.
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe.
Overview: This five-year study is designed for women who are post-menopausal and at a higher risk of developing breast cancer, due to either a personal or family history of breast cancer. The study compares Exemestane, a drug that is already FDA approved for treating certain types of breast cancer, to a placebo (a sugar pill) taken once a day for five years.
Qualifications: Women must be 35 or older and post-menopausal for at least one year. This can be natural menopause or due to surgery. Calculations are performed to confirm that the potential patient is at a higher risk of developing breast cancer and these calculations must at least meet the minimum number to qualify. Women must not have taken hormone replacement therapy within the past 90 days.
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
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Topic: Breast Cancer
Title: NSABP PROTOCOL BP-59, Bone Marrow Analysis in Early-Stage Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Diagnostic procedures that detect tumor cells in the bone marrow may help doctors predict disease recurrence and plan more effective treatment. This clinical trial is studying how well diagnostic procedures work in detecting tumor cells in the bone marrow of patients who have undergone surgery for stage I, stage II, or stage IIIA breast cancer. Patients undergo bone marrow aspiration during surgical resection of the primary tumor. Bone marrow cells and tumor samples are analyzed using bright field immunocytochemistry and multicolor fluorescence immunocytochemistry. Patients are followed every 12 months for up to 10 years. A total of 1,634 patients will be accrued for this study within three years.
Qualifications: Eligible patients must be at least 18 years of age and have early-stage breast cancer.
How to sign up: Call (513) 584-7698 or 1 (888) 724-5959.
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Topic: Breast Cancer
Title: S0715, Randomized Placebo-controlled Trial of Acetyl-L-Carnitine (ALC) For the Prevention of Taxane Induced Neuropathy, Phase III.
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe
Overview: This randomized, phase III clinical trial will compare the effects, good and/or bad, of the dietary supplement Acetyl-L-Carnitine (ALC) with placebo (contains no active drug) on neuropathy, to find out which is better. Neuropathy (a side effect of taxane-based drugs) is a feeling of pain, numbness, and tingling in the extremities (such as the hands, feet, arms and legs), and a reduced ability for the extremities to function properly. The study will also compare the effects of ALC with placebo on fatigue (a feeling of tiredness), also a side effect of taxane-based drugs. Patients will be placed in one of two groups; one group will receive ALC (the study drug) the other group will receive placebo (which contains no drug). Each group, whether study drug or placebo, will take two capsules by mouth three times per day for 24 weeks. After you finish taking the study medication, the study doctor will ask you to visit the office for follow-up exams at week 36, year 1 and year 2. A total of 380 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have breast cancer that will be treated with a taxane-based therapy.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Breast Cancer Cancer
Title: NSABP B-40, A Randomized Phase III Trial of Neoadjuvant Therapy in Patients with Palpable and Operable Breast Cancer Evaluating the Effect on Pathologic Complete Response (pCR) of Adding Capecitabine or Gemcitabine to Docetaxel when Administered before AC with or without Bevacizumab and Correlative Science Studies Attempting to Identify Predictors of High Likelihood for pCR with each of the Regimens.
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of breast cancer by blocking blood flow to the tumor. Giving chemotherapy and bevacizumab before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed. Giving bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known which chemotherapy regimen is more effective with or without bevacizumab in treating breast cancer.
In this research study, eligible patients in Arm I receive docetaxel IV over 60 minutes on day one. Treatment repeats every three weeks for up to four courses. Patients then receive AC comprising doxorubicin hydrochloride IV over 15 minutes and cyclophosphamide IV over 30 minutes on day one. Treatment repeats every three weeks for up to four courses. Patients then undergo surgery (lumpectomy or mastectomy). Eligible patients in Arm II receive bevacizumab IV over 30-90 minutes on day one and docetaxel as in Arm I. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I and II additional courses of bevacizumab concurrent with the first two courses of AC. Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab IV over 30 minutes on day one. Treatment repeats every three weeks for up to 10 courses in the absence of disease progression or unacceptable toxicity. Eligible patients in Arm III receive docetaxel as in Arm I and oral capecitabine twice daily on days 1-14. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Eligible patients in Arm IV receive bevacizumab as in Arm II and docetaxel and capecitabine as in Arm III. Treatment repeats every three weeks for up to four courses. Patients then receive bevacizumab IV over 30 minutes on day one and AC as in Arm I. Treatment repeats every three weeks for up to four courses (two courses of bevacizumab). Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab as in Arm II. Eligible patients in Arm V receive docetaxel as in Arm I and gemcitabine hydrochloride IV over 30 minutes on days one and eight. Treatment repeats every three weeks for up to four courses. Patients then receive AC as in Arm I. Patients then undergo surgery as in Arm I. Eligible patients in Arm VI receive docetaxel as in Arm I, gemcitabine hydrochloride as in Arm V, and bevacizumab as in Arm II. Patients then receive AC with bevacizumab as in Arm II. Patients then undergo surgery as in Arm I. At least four to six weeks after surgery, patients receive adjuvant bevacizumab as in Arm II.
After completion of study treatment, patients are followed periodically for 10 years.
About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 1,200 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age, have breast cancer and have not yet had surgery to remove the tumor.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
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Topic: Breast Cancer
Title: ECOG PACCT-1 Trial-Program for the Assessment of Clinical Cancer Tests (PACCT-1):Trial Assigning Individualized Options for Treatment: The TAILORx Trial
Enrollment Dates: August 2006 startup
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: This study is being done because chemotherapy would normally be recommended for the treatment of this disease to lower the risk of breast cancer recurring. The purpose of this study is to determine whether patients who have a tumor with a recurrence score equal to or below 10 may be cured with hormonal therapy alone. Another objective is to create a tissue and blood specimen bank that includes specimens from all women who participate in the study so as to allow researchers to evaluate new diagnostic tests for the future.
Qualifications: To qualify for this trial, women must be age 18 or older and have breast cancer that is estrogen receptor and/or progesterone receptor positive and has not spread to the auxiliary lymph nodes.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
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Topic: Breast Cancer
Title: NSABP PROTOCOL B-42: A Clinical Trial to Determine the Efficacy of Five Years of Letrozole Compared to Placebo in Patients Completing Five Years of Hormonal Therapy Consisting of an Aromatase Inhibitor (AI) or Tamoxifen Followed by an AI in Prolonging Disease-Free Survival in Postmenopausal Women with Hormone Receptor Positive Cancer
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: The main purpose of the study is to learn whether or not continuing hormonal therapy with an aromatase inhibitor (AI) called letrozole for five additional years after already taking five years of hormonal therapy (which included an AI) can further reduce the chance of breast cancer recurrence. Letrozole is investigational (still being researched) for use in patients who have already received an AI as part of their five years of hormonal therapy. Letrozole is considered investigational because it has not yet received approval from the Food and Drug Administration (FDA) or the Canadian Health Products and Food Branch (HPFB) for use after five years of hormonal therapy which included an AI. Eligible patients will be randomized to receive either letrozole 2.5 mg or a placebo that looks like letrozole. Letrozole/placebo should begin within 30 days following randomization and is to be given continuously for five years from the date of the first dose (regardless of missed doses or drug holidays). After completing the letrozole/placebo, study staff will contact patients every year for the rest of their lives to follow their health.
Qualifications: Postmenopausal women with ER and/or PgR-positive invasive breast cancer who have completed five years of hormonal therapy consisting of either five years of an aromatase inhibitor (AI) or up to three years of tamoxifen followed by an AI (for a total of five years).
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
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Topic: Breast Cancer
Title: SWOG S0622, Phase II Studies of Two Different Schedules of Dasatinib (NSC-732517) in Bone-Metastasis Predominant Metastatic Breast Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building and University Pointe
Overview: Dasatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. This randomized, phase II trial is studying two different schedules of dasatinib to compare how well they work in treating patients with stage IV breast cancer that has spread to the bone. Eligible patients are stratified according to concurrent trastuzumab (Herceptin®) treatment (yes vs. no). Patients are randomized to one of two treatment arms. Arm I: Patients receive oral dasatinib once daily. Arm II: Patients receive oral dasatinib twice daily. In both treatment arms, treatment continues for at least 24 weeks in the absence of disease progression or unacceptable toxicity. Blood samples are acquired from patients once weekly in weeks one, four, eight, 16, and 24. Samples are analyzed for tumor markers, circulating tumor cells, and bone markers. Patients complete a self-reported brief pain inventory questionnaire at baseline and once in weeks eight, 16, and 24. After completion of study treatment, patients are followed every three to six months for up to two years. A total of 80 patients will be accrued for this study, with about four accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have breast cancer that has spread to other parts of the body.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
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Topic: Metastatic Breast Cancer
Title: SWOG S0500, A Randomized Phase III Trial to Test the Strategy of Changing Therapy Versus Maintaining Therapy for Metastatic Breast Cancer Patients who have Elevated Circulating Tumor Cell levels at First Follow Up Assessment
Trial Dates: Ongoing
Place: The Barrett Center; The Medical Arts Building; University Pointe; VA Medical Center
Overview: Metastatic Breast Cancer is breast cancer that has spread to another part of the body. The purpose of this study is to find out if the CellSearch blood test, which identifies tumor cells in the blood, can predict survival outcomes in patienst that have Metastatic Breast Cancer. The CellSearch blood test may allow physicians to tell if your current chemotherapy is not working before your cancer becomes worse. This study will test whether switching to another form of treatment based upon the results of the CellSearch blood test helps people live longer. Also, the study is to confirm results which suggested patients that have < 5 CTCs before they begin treatment are more likely to live longer than those with > 5 CTCs.
Eligible patients are placed into a treatment group by chance (randomized). Treatment and chosen group (randomization) will be decided upon from blood work that will measure circulating tumor cells (CTCs), which all patients will have measured. All patients will be told of their results of the first CTC test.
After completion of the study, patients are followed with collection of blood specimen?s, information about your treatment and progress until your cancer has worsened. Ideally, we would like to keep track of your medical condition for a minimum of 5 years, with every 6 months your doctor sending us an update on your condition.
About five (5) people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately five hundred (500) people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18, Female, and have cancer that has spread to other parts of the body.
How to sign up: Please contact U.C. Cancer Center with any questions, (513) 584-7698 or (888) 724-5959. You will be connected to the Research Coordinator for this study.
Gastronintestinal Cancer Clinical Trials
Topic: Esophageal Cancer
Title: Z4051, A Phase II Study of Neoadjuvant Therapy With Cisplatin, Docetaxel, Panitumumab Plus Radiation Therapy Followed by Surgery in Patients With Locally Advanced Adenocarcinoma of the Distal Esophagus
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview:
The goal of this phase II trial is to improve the chances that your esophageal tumor will shrink and/or disappear by adding an investigational drug to routine chemotherapy and radiation before surgery. This drug is a monoclonal antibody that blocks a target at the molecular level that when "turned on" causes reactions that make your tumor grow and spread. This drug is called panitumumab.
You will receive panitumumab in combination with two other chemotherapy drugs called cisplatin and docetaxel every 2 weeks for 10 weeks. You also will receive radiation therapy at the same time as the chemotherapy starting week 5.
You will be in the study for about 3 years. You will be asked to take chemotherapy and radiation therapy for 10 weeks. After you finish therapy and have surgery, you will see your study doctor at 30 days, then every 3 months for 2 years, then every 6 months for 1 year.
A total of approximately 69 patients will enroll in this study across the country, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have cancer of the esophagus.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Esophageal Cancer
Title: R0436, A Phase III Trial Evaluating the Addition of Cetuximab to Paclitaxel, Cisplatin, and Radiation for Patients With Esophageal Cancer Who Are Treated Without Surgery
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This randomized phase III trial is comparing how well giving paclitaxel and cisplatin together with radiation therapy works with or without cetuximab in treating patients with locally advanced esophageal cancer. Drugs used in chemotherapy, such as paclitaxel and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Cetuximab may stop the growth of esophageal cancer by blocking blood flow to the tumor. It is not yet known whether giving paclitaxel and cisplatin together with radiation therapy is more effective with or without cetuximab in treating esophageal cancer.
In arm I patients receive cetuximab IV over 1-2 hours, paclitaxel IV over 1 hour, and cisplatin IV over 30-60 minutes on days 1, 8, 15, 22, 29, and 36. Patients also undergo radiotherapy once daily, 5 days a week, for 5½ weeks. In arm II patients receive paclitaxel and cisplatin as in arm I. Patients also undergo radiotherapy as in arm I.
A total of 420 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have esophageal cancer that is considered appropriate for treatment with a combination of chemotherapy and radiation. Based on the fact that your cancer started in the esophagus and you have not yet received any treatment for your cancer, you may be eligible for participation.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Cholangiocarcinoma
Title: SWOG 0809 A Phase II Trial of Adjuvant Capecitabine/Gemcitabine Chemotherapy Followed by Concurrent Capecitabine and Radiotherapy in Extrahepatic Cholangiocarcinoma (EHCC)
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: Drugs used in chemotherapy, such as capecitabine and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Giving more than one drug (combination chemotherapy) together with radiation therapy may kill more tumor cells. This phase II trial is studying how well giving capecitabine together with gemcitabine followed by capecitabine and radiation therapy works in treating patients with cholangiocarcinoma of the gallbladder or bile duct. This is a multicenter study. Patients are stratified according to margin of resection (negative [R0] vs microscopically positive [R1]).
Adjuvant chemotherapy: Patients receive oral capecitabine every 12 hours on days 1-14 and gemcitabine hydrochloride IV over 30 minutes on days 1 and 8. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
Chemoradiotherapy: Beginning in week 13, patients receive oral capecitabine every 12 hours on days 1-7. Patients also undergo concurrent three-dimensional or intensity-modulated radiotherapy on days 1-5. Treatment repeats weekly for 5-6 weeks in the absence of disease progression or unacceptable toxicity.
A total of 80 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have had surgery for extrahepatic cholangiocarcinoma (cancer of the bile duct or gallbladder)
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Study of Oxaliplatin-induced neuropathy in patients with colorectal cancer
Title: Phase II Study of the Efficacy of Amifostine (Ethyol) in Reducing the Incidence and Severity of Oxaliplatin-Induced Neuropathy in Patients with Colorectal Cancer
Enrollment Dates: August 2006 through August 2008
Place: The Barrett Center
Overview: This study will evaluate the use of intravenous Amifostine for reducing the incidence of oxaliplatin-induced neuropathy in patients with colorectal cancer.
Qualifications: Qualified participants must be 18 years of age or older and diagnosed with colorectal cancer
How to sign up: Call (513) 584-7698 or (866) 724-CURE.
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Topic: Colorectal
Title: SWOG S0600, Phase III Trial of Irinotecan-Based Chemotherapy Plus Cetuximab (NSC-714692) with or without Bevacizumab (NSC-704865) as Second-Line Therapy for Patients with Metastatic Colorectal Cancer who have Progressed on Bevacizumab with Either FOLFOX, OPTIMOX or XELOX
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying irinotecan and cetuximab to compare how well they work with or without bevacizumab in treating patients with metastatic colorectal cancer that progressed during first-line therapy. Eligible patients are stratified according to Zubrod performance status, discontinuation of oxaliplatin during first-line therapy, planned concurrent chemotherapy (FOLFIRI vs. single-agent irinotecan hydrochloride), and time from last dose of bevacizumab (14-42 days vs. ? 43 days). All patients receive either single-agent irinotecan hydrochloride (by IV every 21 days in the absence of disease progression or unacceptable toxicity) or FOLFIRI (by IV every 14 days in the absence of disease progression or unacceptable toxicity). Patients are then randomized to one of three treatment arms. Arm I: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab IV. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in Arm I. Patients also receive bevacizumab IV. Courses repeat every 14-21 days (depending upon chemotherapy regimen) in the absence of disease progression or unacceptable toxicity. Arm III: Patients receive single-agent irinotecan hydrochloride or FOLFIRI as outlined above and cetuximab as in Arm I. Patients also receive a higher dose of bevacizumab IV (higher than in Arm II). After completion of study treatment, patients are followed every six months for up to three years. A total of 1,260 patients will be accrued for this study, with about 10 accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have colorectal cancer that has spread and that has not responded to prior treatment that included bevacizumab.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
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Topic: Carcinoid
Title: SWOG S0518, Phase III Prospective Randomized Comparison of Depot Octreotide plus Interferon Alpha versus Depot Octreotide plus Bevacizumab (NSC #704865) in Advanced, Poor Prognosis Carcinoid Patients
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying giving octreotide in combination with interferon alfa-2b to see how well it works compared with giving octreotide in combination with bevacizumab in treating patients with metastatic or locally advanced, high-risk neuroendocrine tumor. Octreotide and interferon alfa-2b may interfere with the growth of tumor cells and slow the growth of cancer. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether giving octreotide in combination with interferon alfa-2b is more effective than giving octreotide in combination with bevacizumab in treating patients with neuroendocrine tumor. Eligible patients are stratified according to site of disease (small bowel vs. cecum vs. appendix vs. other site), disease progression after initial diagnosis (yes or no), histologic grade (low vs. intermediate [atypical]), and prior octreotide acetate therapy within the past two months (yes vs. no). Patients are randomized to one of two treatment arms. Patients in Arm I receive depot octreotide acetate intramuscularly (IM) and bevacizumab IV over 30-90 minutes on day one. Patients in Arm II receive octreotide acetate IM as in Arm I on day one and interferon alfa-2b subcutaneously (SC) on days one, three, five, eight, 10, 12, 15, 17, and 19. Treatment in both arms repeats every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every two to six months for up to three years.
Qualifications: Eligible patients must be at least 18 years of age and have neuroendocrine carcinoma (carcinoid tumor) that cannot be removed by surgery and has either grown or has at least one feature that suggests it may grow during the period of the study.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
Genitourinary Cancer Clinical Trials
Topic: Renal (kidney) cancer
Title: CTSU E2805, A Randomized, Double-Blind Phase III Trial of Adjuvant Sunitinib versus Sorafenib versus Placebo in Patients with Resected Renal Cell Carcinoma
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Sunitinib and sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Giving sunitinib or sorafenib after surgery may kill any tumor cells that remain after surgery. It is not yet known whether sunitinib is more effective than sorafenib or placebo in treating kidney cancer. This randomized phase III trial is studying sunitinib to see how well it works compared to sorafenib or placebo in treating patients with kidney cancer that has been removed by surgery. A total of about 1,332 people will take part in this study at multiple institutions across the country, with approximately five participating locally.
Qualifications: Qualified participants must be at least 18 years of age and have kidney cancer which has just been removed or is about to be removed and is thought to be at high risk of recurrence.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
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Topic: Prostate Cancer
Title: RTOG 0621, Adjuvant 3DCRT/IMRT in Combination with Androgen Suppression and Docetaxel for High Risk Prostate Cancer Patients Post-Prostatectomy: A Phase II Trial
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This phase II trial is studying how well giving radiation therapy together with androgen suppression and docetaxel works in treating patients with high risk prostate cancer who have undergone radical prostatectomy. Specialized radiation therapy that delivers a high-dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as leuprolide, goserelin, flutamide, or bicalutamide, may lessen the amount of androgens made by the body. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with androgen suppression and docetaxel after surgery may kill any tumor cells that remain after surgery. Androgen suppression therapy: Patients receive a luteinizing hormone-releasing hormone (LHRH) agonist (leuprolide or goserelin) as an injection AND an oral antiandrogen (flutamide 3 times daily or bicalutamide once daily) for up to 6 months. Beginning 8 weeks after the initiation of androgen suppression therapy, patients undergo 3-dimensional conformal radiotherapy or intensity-modulated radiotherapy once a day 5 days a week for up to approximately 8 weeks. Beginning 3-6 weeks after the completion of radiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 21 days for up to 6 courses.
After the completion of study treatment, patients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.
Qualifications: Eligible patients must be at least 18 years old and you have prostate cancer that has been treated surgically and it has been determined that you have a 50% or greater risk of recurrence of your prostate cancer within 3 years following surgery.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Prostate Cancer
Title: RTOG 0534, A Phase III Trial Of Short Term Androgen Deprivation With Pelvic Lymph Node Or Prostate Bed Only Radiotherapy (SPPORT) In Prostate Cancer Patients with A Rising PSA after Radical Prostatectomy
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying prostate radiation therapy to see how well it works compared with short-term androgen deprivation therapy given together with pelvic lymph node radiation therapy with or without prostate radiation therapy in treating patients with a rising PSA after surgery for prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Androgens can cause the growth of prostate cancer cells. Antihormone therapy, such as flutamide, bicalutamide, and luteinizing hormone-releasing hormone agonist, may lessen the amount of androgens made by the body. It is not yet known which regimen of radiation therapy with or without androgen deprivation therapy is more effective for prostate cancer. Eligible patients will be put in to three different treatment groups: 1) Patients who receive radiation therapy to the prostate bed only; 2) Patients who receive hormone therapy for four to six months plus radiation therapy to the prostate bed; and 3) Patients who receive hormone therapy for four to six months plus radiation therapy to the prostate bed and to the pelvic lymph nodes. Patient will receive 36?39 radiation treatments over seven to eight weeks. Hormone therapy, if given, will last four to six months. After radiation therapy, participants complete follow-up exams every three months for the first year, then every six months for the next four years. A total of about 1,764 people will take part in this study, with about five people participating locally.
Qualifications: Eligible patients must be at least 18 years old and have had surgery to remove the prostate and be recommended for radiation therapy due to a rise in levels of Prostate Specific Antigen (PSA).
How to sign up: Call 513-584-7698 or 1-888-724-5959.
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Topic: Prostate Cancer
Title: CALGB 90202, A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: This randomized phase III trial is studying how well zoledronate works in preventing bone-related events in patients who are receiving androgen deprivation therapy for prostate cancer and bone metastases. Zoledronate may prevent or decrease skeletal (bone)-related events (such as pain or fractures) caused by bone metastases and androgen deprivation therapy. It is not yet known whether treatment with zoledronate is effective in preventing bone-related events in patients who have prostate cancer and bone metastases.
This is a randomized, double-blind, placebo-controlled, multicenter study followed by an open-label study. Patients are stratified according to ECOG performance status (0-1 vs. 2), prior skeletal-related event (no vs. yes), and serum alkaline phosphatase (< upper limit of normal [ULN] vs. ULN). Patients are randomized to one of two treatment arms. Patients in Arm I receive zoledronate IV over 15 minutes on day one. Patients in Arm II receive placebo IV over 15 minutes on day one. In both arms, courses repeat every four weeks in the absence of disease progression or a skeletal-related event. All patients receive concurrent androgen deprivation therapy. Patients also receive oral calcium and cholecalciferol (vitamin D) supplements daily.
Patients progressing to androgen-independent prostate cancer proceed to open-label therapy comprising zoledronate IV over 15 minutes on day one. Courses repeat every three weeks in the absence of disease progression or a skeletal-related event. Patients are followed periodically for approximately 10 years after randomization. Projected accrual is a total of 680 patients (340 per treatment arm) will be accrued for this study within four years.
Qualifications: Qualified participants must be at least 18 years of age and have uveal melanoma that has returned after treatment or has spread to other parts of his/her body.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
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Topic: Prostate Cancer
Title: E3805, CHAARTED: ChemoHormonal Therapy Versus Androgen Ablation Randomized Trial for Extensive Disease in Prostate Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview:
The purpose of this study is to evaluate a new way of treating patients with prostate cancer. The trial is to determine whether receiving docetaxel (a type of chemotherapy) both when you start hormone therapy (or within 120 days of beginning hormonal therapy) as well as when your disease worsens, is better than only receiving docetaxel when your disease gets worse. This trial will let us know which approach is more effective in treating your disease.
There are two ?Arms? or types of therapy given in this study. In Arm A, you will receive docetaxel chemotherapy both at the time you are starting hormonal therapy and later when/if the hormonal therapy is no longer working per your doctor decision. In Arm B, patients only get chemotherapy when/if the hormonal therapy is no longer working per your doctor decision. We are doing the study to see if there is a benefit to giving chemotherapy at the beginning. Hormonal therapy refers to drugs or surgical procedures such as an orchiectomy (removal of testicles) which lower your testosterone. This puts prostate cancer into remission in most patients as the testosterone is like a fuel for the cancer. It is the standard to give this as the only treatment for your cancer. Normally chemotherapy is reserved for when a patient?s cancer starts to grow again despite having a low testosterone level. In this study you will either get docetaxel when you start your hormonal therapy or when/if your cancer grows with a low testosterone level. If you have chemotherapy when you start hormones for the first time, you may get chemotherapy when/if your cancer grows back with a low testosterone level.
You will be in the treatment period of the study for several months. The study doctors would like to keep track of your medical condition for a period of 10 years after entering the study, to look at the long-term effects of the treatment.
A total of approximately 600 patients will be accrued for this study across the country, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have prostate cancer that has spread beyond the prostate and can be seen on scans.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic:
Prostate Cancer
Title: SWOG S0421, Phase III Study of Docetaxel and Atrasentan versus Docetaxel and Placebo For Patients with Advanced Hormone Refractory Prostate Cancer
Enrollment Dates: Ongoing
Place: The Barrett Cancer Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Drugs used in chemotherapy, such as docetaxel, prednisone, and atrasentan work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known whether docetaxel, prednisone, and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer. This randomized phase III trial is studying docetaxel, prednisone, and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy.
Eligible patients are randomized to one of two treatment arms. Patients in Arm I receive docetaxel IV over one hour on day one. Patients also receive oral atrasentan and oral prednisone once daily on days one through 21. Treatment repeats every 21 days for up to 12 courses. Patients in Arm II receive docetaxel and prednisone as in Arm I. Patients also receive oral placebo once daily on days one through 21. Treatment repeats every 21 days for up to 12 courses. After completion of study treatment, patients are followed every three months for one year and then every six months for up to three years from study entry. About five people will take part in the study at the University of Cincinnati and the Department of Veterans Affairs Medical Center. Approximately 930 people will take part in this study at multiple institutions across the country.
Qualifications: Qualified participants must be at least 18 years of age and have prostate cancer that is not responding well to treatment.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
Head and Neck Cancer Clinical Trials
Topic: Head & Neck
Title: RTOG 0619, A Randomized Phase II Trial of Chemoradiotherapy Versus Chemoradiotherapy and Vandetanib for High-Risk Postoperative Advanced Squamous Cell Carcinoma of the Head And Neck
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This randomized phase II trial is studying giving chemotherapy together with radiation therapy to see how well it works compared with giving chemotherapy and radiation therapy together with vandetanib in treating patients with high-risk stage III or stage IV head and neck cancer.
Drugs used in chemotherapy, such as cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether giving chemotherapy together with radiation therapy is more effective with or without vandetanib in treating patients with head and neck cancer. Arm I: Active Comparator: Patients undergo radiotherapy 5 times a week for up to 6.5 weeks and receive cisplatin IV over 1 hour on days 1, 22, and 43 of radiotherapy.
Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity. Arm II: Experimental : Patients undergo radiotherapy as in arm I and receive cisplatin IV over 1 hour once a week beginning on day 1 of radiotherapy. Patients also receive oral vandetanib once daily beginning 14 days prior to the start of radiotherapy. Treatment continues for 6 weeks in the absence of disease progression or unacceptable toxicity.
Qualifications: Eligible patients must be at least 18 years old and have advanced head and neck cancer and have had surgery to remove your cancer.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
Leukemia Clinical Trials
Topic: Leukemia
Title: S0703, A Phase II Trial of Azacitidine (NSC-102816) Plus Gemtuzumab Ozogamicin as Induction and Post-Remission Therapy in Patients of Age 60 and Older With Previously Untreated Non-M3 Acute Myeloid Leukemia
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This phase II trial is studying the side effects of giving azacitidine together with gemtuzumab to see how well it works in treating older patients with previously untreated acute myeloid leukemia. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Azacitidine may also stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Monoclonal antibodies, such as gemtuzumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Giving azacitidine together with gemtuzumab may kill more cancer cells.. Patients with residual leukemia (blast count ? 5%) receive a second course of induction therapy beginning between days 15-22. Patients achieving complete remission (CR) or morphologic complete remission with incomplete blood count recovery (CRi) go on to receive consolidation therapy. Consolidation therapy: Patients receive one course of azacitidine and gemtuzumab ozogamicin as in induction therapy. After completion of study therapy, patients are followed every 2 months for 2 years, every 3 months for 1 year, every 4 months for 1 year, and then every 6 months there after.
A total of 45-139 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 60 years old and have untreated acute myeloid leukemia
How to sign up:Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic:
Leukemia
Title: SWOG S0605, A Phase II Study of Lenalidomide (Revlimid) (NSC-703813) for Previously Untreated Non-M3 Deletion 5Q Acute Myeloid Leukemia (AML) in Patients Age 60 or Older Who Decline Remission Induction Chemotherapy
Enrollment Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Biological therapies, such as lenalidomide, may stimulate the immune system in different ways and stop cancer cells from growing. This phase II trial is studying how well lenalidomide works in treating older patients with acute myeloid leukemia with abnormal chromosome 5q. During the first part of the study (Induction therapy), patients receive oral lenalidomide once daily on days one through 14, one through 21, or one through 28 (course one). Patients undergo bone marrow biopsy on day 28 or 35 to assess treatment efficacy. Patients with stable or improving disease (i.e., a decrease in blast percentage) without progressive disease proceed to maintenance therapy. During the second part of the study (Maintenance therapy), beginning within 42 days after completion of induction therapy, patients receive oral lenalidomide once daily on days one through 21. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed periodically for up to five years. A total of about 40 patients will be put on this study, with approximately five patients participating locally.
Qualifications: Qualified participants must be at least 18 years of age and have acute myeloid leukemia (AML) that has not been treated.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
Lung Cancer Clinical Trials
Topic: Lung Cancer
Title: ACOSOG Z4032 A Randomized Phase III Study of Sublobar Resection versus Sublobar Resection plus Brachytherapy in High Risk Patients with Non-Small Cell Lung Cancer (NSCLC), 3 cm or Smaller.
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hospital, Veterans Affairs Medical Center and University Pointe
Overview: The purpose of this study is to compare the results of sublobar resection (removal of a small portion of a lung) with sublobar resection and brachytherapy (radiation seed implants) on lung cancer.
Qualifications:
- Must be at least 18 year of age
- Must have a suspicious lung nodule for stage I NSCLC
- Must have a mass no more than three cm diameter based on CT scan
- Must not have had previous intra-thoracic radiation therapy
- Women able to have children must have a negative pregnancy test
How to sign up: Call (513) 584-7698 or (888) 724-5959.
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Topic: Lung
Title: S0720, Phase II ERCC1 and RRM1-Based Adjuvant Therapy Trial in Patients With Stage I Non-Small Cell Lung Cancer (NSCLC)
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview: This phase II trial is studying how well giving gemcitabine together with cisplatin works in treating patients with stage I non-small cell lung cancer that was removed by surgery. Drugs used in chemotherapy, such as gemcitabine and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving chemotherapy drugs after surgery may kill any tumor cells that remain after surgery. Sometimes, after surgery, the tumor may not need more treatment until it progresses. In this case, observation may be sufficient. In Arm1, no intervention, patients undergo active monitoring after surgery with disease assessments at 8, 16, and 24 weeks. In Arm 2, experimental, beginning within 84 days after surgery, patients receive gemcitabine hydrochloride IV over 30 minutes on days 1 and 8 and cisplatin IV over 30-90 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity.
A total of 55 patients will be accrued for this study, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and have histologically confirmed non-small cell lung cancer
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Non Small Cell Lung Cancer Research Study
Title: A Double Blind, Randomized, Placebo Controlled Phase III Study to assess the efficacy of rec,AGE-A3 + AS15 ASCI Antigen-Specific Cancer Immunotherapeutic as adjuvant therapy in patients with resectable MAGE-A3 positive Non Small Cell Lung Cancer
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe
Overview: Even with operation and adjuvant therapy (after surgery) chemotherapy, there is still a risk that your cancer may recur (come back). This research study is being done to try and find additional ways to prevent cancer from recurring. This investigational anti-cancer treatment, called MAGE-A3, is being studied to see if it can teach your body?s immune system to fight cancer in the same way that it fights infection from germs or viruses. Investigational means that it has not been approved by the Food and Drug Administration (FDA). It is the hope that any recurrence of cancer will be delayed or prevented.
The purpose of this study is to see whether this type of anti-cancer treatment works, and, if it does, to measure its effectiveness with more precision. A portion of the cancer tissue that has been removed during your operation will be sent to a laboratory in order to see if it produces MAGE-A3 protein.
After this screening procedure, the study doctor will tell you whether or not you meet the requirements to participate in a research study. If it is found that your tumor produces MAGE-A3, then you will be informed and given more information about the clinical study.
Qualifications: Eligible Participants must be at least 18 years old, and have been diagnosed with non small cell lung cancer for which you have had, or will be having surgery. In addition, your treatment must not involve receiving chemotherapy after the operation.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic:
Lung Cancer
Title: CTSU E1505, A Phase III Randomized Trial of Adjuvant Chemotherapy With or Without Bevacizumab for Patients With Completely Resected Stage IB-IIIA Non-Small Lung Cancer (NSCLC)
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Overview: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab also may stop the growth of tumor cells by blocking blood flow to the tumor. Giving chemotherapy in combination with bevacizumab after surgery may kill any tumor cells that remain after surgery. It is not yet known whether chemotherapy is more effective with or without bevacizumab in treating non-small cell lung cancer.
This randomized phase III trial is studying chemotherapy and bevacizumab to see how well they work compared to chemotherapy alone in treating patients with stage IB, stage II, or stage IIIA non-small cell lung cancer that was removed by surgery.
Qualified patients are stratified according to type of chemotherapy (cisplatin/vinorelbine ditartrate vs. cisplatin/docetaxel vs. cisplatin/gemcitabine hydrochloride), stage (IB vs. II vs. IIIA [N2] vs. IIIA [T3, N1]), histology (squamous cell vs. other), and gender. Patients are randomized to one of two treatment arms: Arm I (adjuvant chemotherapy without bevacizumab) or Arm II (adjuvant chemotherapy with bevacizumab). Treatment with bevacizumab repeats every 21 days for up to one year. Patients complete smoking status questionnaires at baseline and then every three months during study treatment. After completion of study treatment, patients are followed periodically for 10 years.
A total of 1,500 patients will be accrued for this study, with about 10 accrued locally.
Qualifications: Eligible patients must be at least 18 years of age and have non-small cell lung cancer, which has been removed by a surgeon.
How to sign up: Call 513-584-7698 or 1-888-724-5959.
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Topic Topic: Lung Cancer
Title: RTOG 0617, Randomized Phase III Comparison of Standard-Dose (60 Gy) Versus High-Dose (74 Gy) Conformal Radiotherapy with Concurrent and Consolidation Carboplatin/Paclitaxel in Patient's with Stage IIIA/IIIB Non-Small Cell Lung Cancer
Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center
Trial Dates: Ongoing
Overview: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether high-dose radiation therapy is more effective than standard-dose radiation therapy when given together with combination chemotherapy in treating patients with non-small cell lung cancer. This randomized phase III trial is studying high-dose radiation therapy given together with chemotherapy to see how well it works compared with standard-dose radiation therapy and chemotherapy in treating patients with newly diagnosed stage III non-small cell lung cancer that cannot be removed by surgery.
Eligible patients will be randomly assigned (have an equal chance of being placed) to one of two treatment groups. Patients in Group One will undergo low-dose radiation therapy fvie days a week for six weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks one through four and six and twice in week five. Patients in Group Two will undergo high-dose radiation therapy five days a week for seven and a half weeks. They will also receive a one-hour infusion of paclitaxel and an infusion of carboplatin once a week in weeks one through four and six and twice in week five. In week 10, patients will receive a three-hour infusion of paclitaxel and an infusion of carboplatin. Treatment may repeat every three weeks for up to two courses. Patients may undergo tumor tissue, blood, and urine collection periodically for laboratory studies. Quality of life may be assessed at the beginning of the study and periodically during the study. After finishing treatment, patients will be evaluated periodically for five years and once a year thereafter.
Qualifications: Eligibility patients must be at least 18 years old, have no distant metastases or Pancoast tumors, have measurable disease, have had no previous chemotherapy for non-small cell lung cancer, and it must be at least three weeks since chest surgery.
How to sign up: Call (513) 584-7698 or 1-866-724-CURE.
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Topic: Advanced Non-Small Cell Lung Cancer in Women
Title: Paclitaxel Poliglumex (CT-2103)/Carboplatin vs Paclitaxel/Carboplatin for the Treatment of Chemotherapy-Naïve Advanced Non-Small Cell Lung Cancer (NSCLC) in Women with Estradiol > 25pg/mL
Enrollment Dates: October 2007 through January 2008
Place: The Barrett Center and Medical Arts Building
Overview: This study will look at the survival of patients given CT-2103/carboplatin versus patients given paclitaxel/carboplatin. The study will also look at disease control, benefits, response rates, quality of life, safety and tolerability.
Qualifications: Women 18 years of age and older, diagnosed with advanced Non-Small Cell Lung Cancer (NSCLC) who are chemotherapy naïve and have an Estrodiol level of > 30pg/mL. aerodigestive cancers.
How to sign up: Call 513-584-7698 or 1-866-724-CURE.
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Topic: Non Small Cell Lung Cancer
Title: Randomized Phase II Study of Docetaxel or Pemetrexed with or without Cetuximab in Patients with Recurrent to Progressive Non Small Cell Lung Cancer after Platinum-Based Therapy
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe
Overview: This study is being conducted to see if adding cetuximab to chemotherapy is better than chemotherapy alone in the control of your tumor and how long your tumor responds to treatment. Cetuximab is a protein that is an anti growth factor receptor antibody. For the purposes of this study, cetuximab is an investigational drug. About 10 people will take part in this study at the University of Cincinnati, with a total of 760 people across the country and Canada.
Treatment being offered during the study includes Docetaxel, an FDA approved drug for the treatment of non small cell lung cancer; or Pemetrexed, an FDA approved drug for the treatment of non small cell lung cancer with or without Cetuximab. After you and your study physician make a decision about which chemotherapy option is a better option to treat your cancer, you will be assigned to one of the two groups randomly (much like flipping a coin).
Group 1 will receive chemotherapy with cetuximab to treat the tumor. Group 2 will receive chemotherapy alone to treat the tumor. All patients, regardless of group, will receive chemotherapy of docetaxel or pemetrexed once every 3 weeks. Chemotherapy will be given to a maximum of six treatments, each three weeks apart.
Every week you will be evaluated for any side effects you may have from treatment. Depending on the type of side effect, you may not be able to receive chemotherapy or cetuximab until the side effect gets better. Your research doctor will review your health and discuss with you your best treatment options with you.
Upon completion of the study, you will be asked to return every 4 weeks for a follow-up visit where a physical exam, blood tests and possibly a CT scan will be performed. After completion you will be contacted every 3 months for follow-up on your health status.
Qualifications: Eligible patients must be at least 18 years old and have been diagnosed with advanced lung cancer that cannot be cured with surgery, radiation therapy or chemotherapy.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
Lymphoma Clinical Trials
Topic: Non-Hodgkin's Lymphoma
Title: A Phase III Study of Gemcitabine, Dexamethasone, and Cisplatin Compared with Dexamethasone, Cytarabine, and Cisplatin Plus/Minus Rituximab [(R)-GDP vs (R)-DHAP] as Salvage Chemotherapy for Patients with Relapsed or Refractory Aggressive Histology Non-Hodgkin?s Lymphoma Prior to Autologous Stem Cell Transplant and Followed by Maintenance Rituximab versus Observation.
Enrollment Dates: Ongoing
Place: The Barrett Center, University Hospital and University Pointe
Overview: The purpose of this study is to compare the effectiveness of two different chemotherapy treatments in patients with previously treated non-Hodgkin's lymphoma. Patients in the study will first be treated with either two cycles of gemcitabine, cisplatin, and dexamethasone [(R)-GDP] or with dexamethasone, cytarabine, and cisplatin [(R)-DHAP]. Patients with CD20+ B cell disease will have rituximab combined with their treatment. After chemotherapy has been completed, patients will have a stem cell transplant. Enrolled patients will then be assigned to either long term treatment with rituximab or observation alone.
Qualifications: Patients must be at least 18 years of age and have clinically and/or radiologically confirmed non-Hodgkin's lymphoma that has come back or did not respond (shrink or disappear) with prior treatment with chemotherapy. During treatment, patients must use effective contraception (applies to both women and men) if of childbearing potential. Previous surgery is permissible as long as it has been more than two weeks since any major surgery. Patients may have received prior radiation therapy, and it must have been more than four weeks since last completion of radiation therapy.
How to sign up: Call (513) 584-7698 or (888) 724-5959.
Melanoma Clinical Trials
Topic: Melanoma
Title: SWOG E1697 Phase III Randomized study of Four weeks High dose Interferon Alfa-2b in stage T3-T4 or N1 (microscopic) Melanoma.
Enrollment Dates: Ongoing
Place: The Barrett Center and University Hematology Oncology Care
Overview: The purpose of this study is to compare the effects (good and bad) of treatment with a drug called Interferon Alfa-2b after the surgical removal of melanoma versus surgery followed by observation only. The study will compare to see which is better. Qualified patients will be randomized to Arm I: Observation, or Arm II: Four weeks of High dose Interferon Alfa-2b. Follow-up includes physical exam, blood work and CXR every three months for the first two years, then every six months for three years and then yearly.
Qualifications:
- Only patients with initial presentation of primary melanoma.
- Only patients with cutaneous melanoma.
- Patients must be randomized with 84 days of surgery (wide excision with or without lymphadenectomy).
- No metastatic disease.
- No autoimmune disorders.
- No prior chemotherapy, radiation therapy, immunotherapy or vaccine treatment.
How to sign up:
Call (513) 584-7698 or (888) 724-5959.
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Topic: Melanoma
Title: Derma 11482, A double-Blind, randomized, placebo-controlled Phase III study to assess the efficacy of recMAGE-A3 + AS15 ASCI as adjuvant therapy in patients with MAGE-A3 positive resected stage III melanoma
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe, VA Medical Center
Overview:
This research is being done to find out if an investigational treatment can prevent or delay melanoma cancer from coming back compared to receiving a placebo. The investigational treatment consists of a protein that is present in melanoma tumors combined with another protein called an adjuvant. The tumor protein is called MAGE-A3. The adjuvant is called AS15. The investigational treatment is called the recMAGE-A3 Antigen-Specific Cancer Immunotherapeutic or ASCI. This research will test whether injection with ASCI helps the body specifically fight the cancer cells. The investigational treatment is based upon how immunizations or vaccinations work. This research will test whether the immune system can be stimulated to fight the cancer in the same way that the body fights an infection caused by germs. The placebo contains no active treatment.
You will have a 2 out of 3 chance of receiving the investigational treatment and a 1 out of 3 chance of receiving the placebo. This study is double-blind which means that neither you nor the study doctor will know whether you are receiving the study treatment or the placebo.
You will take part in this study for 27 months. You will receive a maximum of 13 injections of the investigational treatment or placebo. You will be followed on this study up to five years after receiving your first study injection.
A total of approximately 1300 patients will be accrued for this study across the country, with approximately 5 patients participating locally.
Qualifications: Eligible patients must be at least 18 years old and it was determined that your tumor made the MAGE-A3 protein.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
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Topic: Melanoma
Title: A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment with OncoVex Compared to Subcutaneously Administered GM-CSF in Previously treated Melanoma Patients with Unresectable Stage IIIB, IIIC and IV Disease
Trial Dates: Ongoing
Place: The Barrett Center, Medical Arts Building, University Pointe
Overview: This research study is being conducted to learn about the safety and risks using OncoVex. OncoVex has shown to destroy tumors in animal tests, which may result in destroying tumors in humans and provided information on the usefulness of OncoVex as a future treatment for melanoma. OncoVex is an investigational drug, which has not yet been approved by the Food and Drug Administration (FDA) and is currently not available, except in this research study. OncoVex is a herpes simplex virus (a microscopic life form commonly known as the “cold sore virus” that has been genetically changed to grow in and destroy cancer cells.
The University of Cincinnati will have approximately 5 people in the research study and approximately 430 people will take part throughout the US, Canada and Europe. Everyone who takes part in this research study, will be given either the study drug OncoVex, or GM-CSF, a study drug approved to be used in participants with leukemia, lymphoma and also used in participants with melanoma. GM-CSF has not been approved by the FDA for use in participants with melanoma and will also be considered investigational for us in this research study. You will be given either OncoVex or GM-CSF randomly (like flipping a coin), although you have twice the likelihood of receiving OncoVex. The dosage of OncoVex and GM-CSF will be determined by the size of your lesions, your weight and height.
You will be in the research study for approximately 1 year and will continue to be followed for 2 years after completion of the study.
Qualifications: Eligible patients must be at least 18 years old and have been diagnosed with melanoma.
How to sign up: Please contact UC Cancer Center with any questions, 513-584-7698 or 1-888-724-5959. You will be connected to the Research Coordinator for this study.
Multiple Myeloma Clinical Trials
There are no trials under this category at this time.
Myelodysplastic Syndrome
There are no trials under this category at this time.
Last Updated 12/30/09
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