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Phase II Chemotherapy with Weekly Aclacinomycin for Stage III/IV Metastatic Breast Carcinoma Previously Treated with Nonanthracycline Agents
Basic Trial Information
Objectives I. Determine the therapeutic efficacy, response rate, and duration of response in patients with metastatic breast cancer treated with aclacinomycin. II. Determine the frequency and extent of alopecia and the frequency of severe cardiotoxicity of aclacinomycin. III. Determine the effect of extravasation of aclacinomycin on local tissues. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with measurable, metastatic, histologically documented adenocarcinoma of the breast who are resistant to cyclophosphamide, 5-fluorouracil, and methotrexate, who may have received vincristine, alkeran, or prednisone, but who have not been treated with anthracyclines. ER-positive tumors must be resistant to hormonal manipulation. There may have been no hormonal or cytotoxic therapy during the 4 weeks prior to entry, and disease must be clearly progressing. The performance status must be at least 50 percent; liver, kidney, and bone marrow function must be in the toxicity range defined as Grade 2 or less. There may be no second primary cancer. Expected Enrollment 29 patients will be entered, with an expected accrual time of 1-2 years; 2 patients have been entered as of November 1981. Protocol closed July 1983. Outline Nonrandomized study. Single-agent Chemotherapy. Aclacinomycin, ACM, NSC-208734.Published Results Gockerman JP, Raney M, Logan T: Phase II evaluation of aclarubicin in advanced breast cancer: a Southeastern Cancer Study Group trial. Cancer Treat Rep 69(9): 1029-1030, 1985. Trial Lead Organizations Southeastern Cancer Study 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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