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Phase III L-PAM/5-FU/MEG Chemotherapy vs ADR/CTX/5-FU/MEG for Primary Stage III or IV Recurrent or Residual Endometrial Cancer
Basic Trial Information
Objectives I. Evaluate the efficacy of treatment with melphalan (L-PAM), 5-fluorouracil (5-FU), and megestrol acetate (MEG) vs. adriamycin (ADR), cyclophosphamide (CTX), 5-FU, and MEG for recurrent or residual adenocarcinoma of the endometrium, primary Stage III or IV. II. Compare clinical response, toxicity and survival in these regimens. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Previously untreated women with primary Stage III, primary Stage IV recurrent or residual endometrial adenocarcinoma, adenocanthoma, or adenosquamous cancer whose potential for cure by radiation therapy or surgery, alone or in combination, is very poor. Patients must have an expected survival time of at least 1 month, a GOG performance rating less than 4, bilirubin not above 3 mg%, BUN not above 25 mg%, creatinine not above 1.5 mg% and a granulocyte count of at least 2000, platelets at least 100,000. Expected Enrollment Protocol closed 10/79. Outline Randomized study. Arm I: 2-Drug Combination Chemotherapy plus Hormone Therapy. Melphalan, L-PAM, NSC-8806; 5-Fluorouracil, 5-FU, NSC-19893; plus Megestrol acetate, MEG, NSC-31423. Arm II: 3-Drug Combination Chemotherapy plus Hormone Therapy. Adriamycin, ADR, NSC-123127; Cyclophosphamide, CTX, NSC-26271; 5-FU, plus MEG.Published Results Cohen CJ, Bruckner HW, Deppe G, et al.: Multidrug treatment of advanced and recurrent endometrial carcinoma: a Gynecologic Oncology Group study. Obstet Gynecol 63 (5): 719-26, 1984.[PUBMED Abstract] Trial Lead Organizations Gynecologic Oncology 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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