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Phase III MEG vs MEG/DES vs Stilphostrol vs STZ for Previously Irradiated Hormone-Refractory Metastatic Prostatic Carcinoma
Basic Trial Information
Objectives I. Compare, in a 4-arm randomized Phase III study, the therapeutic efficacy of megestrol acetate vs. megestrol acetate plus low-dose diethylstilbestrol vs. stilphostrol vs. streptozotocin in patients with advanced carcinoma of the prostate who have received extensive radiotherapy, including at least 2,000 rads to the pelvis or lumbosacral region. II. Study the sequential effects of these agents by a crossover design at progression. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically confirmed cancer of the prostate with documented metastases who have relapsed or have been unresponsive to orchiectomy. Patients must have relapsed after any prior estrogen therapy. Patients may have had prior adrenalectomy or hypophysectomy. The expected survival must be at least 90 days. Patients may not have had any previous cytotoxic chemotherapy, but they must have had extensive radiotherapy, including at least 2,000 rads to the pelvis or lumbosacral region. All hormonal therapy must have ceased at least 14 days prior to entry, and patients must have recovered from the effects of major surgery and be free of significant infection. Liver and bone marrow function must be adequate, and there may be no medically untreatable disease. There may be no history of another neoplasm, with the exception of nonmelanomatous skin cancer, and there may be no history of prior treatment with any of the study agents. Expected Enrollment 103 patients will be entered on each arm over approximately 3 years. Protocol closed July 1985. Outline Randomized study. Arm I: Endocrine Therapy. Megestrol acetate, MEG, NSC-71423. Arm II: Endocrine Therapy. MEG; plus Diethylstilbestrol, DES, NSC-3070. Arm III: Endocrine Therapy. Stilphostrol, STP, NSC-10481. Arm IV: Single-agent Chemotherapy. Streptozotocin, STZ, NSC-85998. Trial Lead Organizations National Prostate Cancer Treatment Group
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol. |
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