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Phase III Chemotherapy with ADR/CTX/CACP Followed by Orchiectomy or Hormone Therapy with DES for Chemotherapy Failures with Metastatic Prostatic Carcinoma
Basic Trial Information
Objectives I. Determine response rate and duration of response among patients with previously untreated metastatic adenocarcinoma of the prostate to aggressive combination chemotherapy with adriamycin/cyclophosphamide/cis-platinum. II. Determine the efficacy of orchiectomy for patients who develop progressive disease on chemotherapy. III. Investigate the utility of steroid hormone receptor protein determinations in predicting the response of prostatic cancer to hormone manipulation (and perhaps to combination chemotherapy) and study whether combination chemotherapy alters the presence or concentration of such proteins in individual patients. IV. Study the effect of sequential chemotherapy and hormone therapy on various endocrinologic parameters and correlate any changes in these parameters with clinical response. V. Investigate the utility of various serial staging procedures in detecting objective responses of this tumor to therapy, including lymphangiography, pelvic CAT scans, urinary hydroxyproline excretion, CEA, and bone marrow acid phosphatase measurements. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with pathologically confirmed adenocarcinoma of the prostate who have pathologically or radiographically documented extrapelvic metastatic disease and who have received no prior chemotherapy, hormone therapy, or radiotherapy to the pelvis or prostatic bed. Patients must be less than 70 years old and have a life expectancy of more than 2 months and a performance scale of 0-2. There may be no brain metastases or spinal cord compression. Hematologic, renal, hepatic, and cardiac function must be adequate. There may be no history of another malignant neoplasm within 5 years prior to entry, except for nonmetastatic skin tumor. Expected Enrollment Protocol closed April 1983. Outline Nonrandomized study. Enter all patients on Regimen A. Enter patients who develop progressive disease on Regimen A to Regimen B. Regimen A: 3-Drug Combination Chemotherapy. Adriamycin, ADR, NSC-123127; Cyclophosphamide, CTX, NSC-26271; cis-Platinum, CACP, NSC-119875; Mannitol, NSC-9256; Nitrogen Mustard, NM, NSC-762, as a substitute for CTX; 5-Fluorouracil, 5-FU, NSC-19893, as a substitute for ADR. Regimen B: Therapy. Orchiectomy or Diethylstilbestrol, DES, NSC-3070. Trial Lead Organizations NCI - Center for Cancer Research
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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