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Phase II/III Chemotherapy with CTX/ADR/MTX/5-FU, with vs without Hormonal Synchronization with TMX/Premarin, for Metastatic Mammary Carcinoma
Basic Trial Information
Objectives I. Compare response rates and duration of responses and proportion of complete remissions for two induction regimens for metastatic breast cancer. II. Evaluate the ability of hormonal therapy to synchronize tumor cells and achieve improved clinical responses, in terms of clinical results and kinetic studies in a small proportion of patients with readily biopsied disease. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically documented mammary carcinoma with evidence of measurable progressive disease, who have received no cytotoxic therapy except adjuvant melphalan. Patients must have a Karnofsky performance index of at least 30, adequate blood counts, and normal liver and kidney function tests, unless abnormalities are due to tumor invasion; under any circumstances, patients with a creatinine of greater than 2.5 mg% are ineligible. Patients may not have a history of malignant neoplasms aside from curatively treated basal cell or squamous cell carcinoma of the skin or surgically cured carcinoma of the cervix in situ. They may not have any medical or psychiatric condition that could contraindicate protocol treatment. Expected Enrollment Approximately 128 patients will be required. Protocol closed July 1983. Outline Randomized study. This trial is a revision of NCI-MB-160, and as of July 1979 patients eligible for NCI-MB-160 enter this study; patients entered prior to that date continue treatment on the original protocol, now designated NCI-MB-160A. As of June 1983, patients with Stage IV inflammatory or Stage III inoperable breast cancer enter NCI-MB-160C; new patients with metastatic breast cancer enter NCI-MB-184. Arm I: 4-Drug Combination Chemotherapy. Cyclophosphamide, CTX, NSC-26271; Adriamycin, ADR, NSC-123127; Methotrexate, MTX, NSC-740; 5-Fluorouracil, 5-FU, NSC-19893. Arm II: 4-Drug Combination Chemotherapy plus 2-Drug Hormonal Therapy. CTX; ADR; MTX; 5-FU; plus Tamoxifen, TMX, NSC-180973; Premarin, Conjugated Estrogens. Trial Lead Organizations NCI - Center for Cancer Research-Medical Oncology
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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