Clinical Trials

Division of Urology

Topic: Prostate Cancer

Title: A Randomized, Open Label, Multicenter, Phase III, 2-Arm Study of Androgen Deprivation with Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Subjects with a Rising PSA Following Definitive Local Therapy

Principal Investigator: R. Bruce Bracken, MD

Enrollment Dates: Ongoing

Place: Division or Urology, Suite 7000 Medical Arts Building

Overview: This study is being conducted in men who have previously undergone a radical prostatectomy as the primary treatment for prostate cancer and who now have a rising PSA value. This is an open label randomized study and participants will randomly be assigned to receive either hormone therapy or hormone therapy plus IV chemotherapy. The hormone therapy is administered by injection once every 3 months and the chemotherapy is administered in 10 doses, once every 3 weeks. The trial will last at least 36 months, with additional follow-up as required.

Qualifications: Qualified participants must be at least 18 years of age and have been diagnosed with prostate cancer that was initially treated with radical prostatectomy and now have a rising PSA value.

How to sign up: Call (513) 558-4060 Barbara Burke

Topic: Prostate Cancer

Title: A Phase III, Randomized, Placebo-controlled, Double-blind Study to Assess the Efficacy and Safety of Once-daily Orally Administered ZD4054 10 mg in Non-Metastatic Hormone Resistant Prostate Cancer

Principal Investigator: R. Bruce Bracken, MD

Enrollment Dates: Ongoing

Place: Division or Urology, Suite 7000 Medical Arts Building

Overview: This study will be conducted in men with prostate cancer that has not spread to another part of the body (non-metastatic) and who are currently on hormone therapy and have a rising PSA value. This randomized phase III trial is studying the effects of a new drug ZD4054 on prostate cancer. The study drug, ZD 4054 or placebo will be taken by mouth once per day. Participants will be followed to see the effect of the medication on the progression of prostate cancer and the tolerability of the study medication. Study participants will be seen every 4 weeks through week 16, at the beginning of the trial, and then every 4 months or more often if requested by the physician.

Qualifications: Qualified participants must be at least 18 years of age and have prostate cancer that is being treated with hormones and have a rising PSA value.

How to sign up: Call (513) 558-4060 Barbara Burke

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Division of Medical Oncology

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

Principal Investigator: Leslie Oleksowicz, MD

Enrollment Dates: Ongoing

Place: The Barrett Center, The Medical Arts Building, University Pointe, 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.

Topic: Prostate Cancer

Title: RTOG 0415 -A Phase III Randomized Study of Hypofractionated 3D-CRT/IMRT versus Conventionally Fractionated 3D-CRT/IMRT in Patients with Favorable-Risk Prostate Cancer

Principal Investigator: Leslie Oleksowicz, MD

Enrollment Dates: Ongoing

Place: Barrett Cancer Center, University Hematology Oncology Care, Veterans Affairs Medical Center and University Pointe

Overview: The purpose of this study is to compare the effects (good and bad) on you and your cancer of the standard dose of radiation therapy (41 treatments over 8 weeks) with a higher daily dose (experimental) of radiation (28 treatments over 5 and a half weeks) to see if the effects of the treatments are similar.

Qualifications:

• Age 18 or older
• Have Prostate Cancer and your doctor has recommended external beam radiation therapy

How to sign up: Call (513) 584-7698 or (888) 724-5959.

Topic: Prostate Cancer

Title: RTOG 0521 A Phase III Protocol of Androgen Suppression (AS) and 3DCRT/IMRT VS AS and 3DCRT/IMRT Followed by Chemotherapy with Docetaxel and Prednisone for Localized High Risk Prostate Cancer

Principal Investigator: Leslie Oleksowicz, MD

Place: Barrett Cancer Center, University Pointe and Veterans Affairs Medical Center

Enrollment Dates: April 2006 to 2012 (approx.)

Overview: The main purpose of this study is to try to find out whether adding chemotherapy to the standard treatment for the patient?s stage of prostate cancer is more effective than the standard treatment by itself. The kind of treatment that most physicians would consider standard for this stage of prostate cancer combines radiation therapy and hormonal therapy. In this study all patients will receive both of these. In addition, half the patients will also receive chemotherapy drugs for about 4-5 months. It is hoped that chemotherapy will be found to provide additional benefit, but chemotherapy has significant side effects. The use of chemotherapy is investigational in this stage of prostate cancer; it needs to be tested to determine if it is beneficial and to find out more about the side effects of the two different treatments.

Qualifications:
Must be at least 18 years of age or older
Must be localized cancer which has not spread to other tissue
Must have physician-diagnosed prostate cancer at high risk for recurrence.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

Topic: Prostate Cancer

Title: RTOG 0518, A Phase III, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy of Zometa® for the Prevention of Osteoporosis and Associated Fractures in Patients Receiving Radiation Therapy and Long Term LHRH Agonists for High-Grade and/or Locally Advanced Prostate Cancer

Principal Investigator: Leslie Oleksowicz, MD

Enrollment Dates: Ongoing

Place: The Barrett Center, Medical Arts Building, University Pointe and Veterans Affairs Medical Center

Overview: Hormone therapy can help to control prostate cancer, but it also can cause bone fractures (breaks).These breaks are a result of weak bones (osteoporosis). The purpose of this study is to compare the effects, good and/or bad, of a drug, zoledronic acid (Zometa®), plus vitamin D and a calcium supplement, with a placebo (an inactive drug) plus vitamin D and a calcium supplement.Zoledronic acid is a drug given through the vein to strengthen bones.Zoledronic acid is approved by the FDA for treatment of cancer-related bone complications (such as weak bones).

The study is being done to find out if zoledronic acid prevents bone fractures by strengthening bones better than vitamin D and calcium alone.In this study, subjects will get zoledronic acid plus vitamin D and a calcium supplement or the placebo plus vitamin D and a calcium supplement. Subjects on this study will receive treatment (or placebo) and will be seen every three months for three years.

Qualifications: Qualified participants must be at least 18 years of age, haveprostate cancer, and be receiving radiation therapy and hormone therapy as part of disease treatment.

How to sign up: Call (513) 584-7698 or (888) 724-5959.

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

Principal Investigator: Leslie Oleksowicz, MD

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).P atients are randomized to 1 of 2 treatment arms.Patients in Arm I receive zoledronate IV over 15 minutes on day 1. Patients in Arm II receive placebo IV over 15 minutes on day 1. In both arms, courses repeat every 4 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 1. Courses repeat every 3 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 4 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.

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

Principal Investigator: Leslie Oleksowicz, MD

Enrollment Dates: Ongoing

Place: The Barrett Cancer Center, Medical Arts Building, University Pointe, 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 1 of 2 treatment arms. Patients in Arm 1 receive docetaxel IV over 1 hour on day 1. Patients also receive oral atrasentan and oral prednisone once daily on days 1-21. 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 1-21. Treatment repeat every 21 days for up to 12 courses. After completion of study treatment, patients are followed every 3 months for 1 year and then every 6 months for up to 3 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) 584-7698or (888) 724-5959.

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UC Cancer Center Clinical Trials