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Phase II Chemotherapy with 4'-Deoxydoxorubicin for Metastatic Renal Carcinoma
Basic Trial Information
Objectives I. Determine the response rate and duration of response among patients with metastatic renal carcinoma treated with 4'-deoxydoxorubicin on a 3-4 week schedule. II. Further delineate the toxicities associated with this agent. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with measurable metastatic adenocarcinoma of the kidney proven histologically, or, when that is not possible, with a compatible renal angiogram or computerized tomography. There may have been no prior chemotherapy, and patients must not have had radiotherapy within 4 weeks of entry and must have recovered from the toxic effects of that treatment. Patients must have an expected survival of at least 6 weeks and a Karnofsky performance status of at least 50 percent. Liver and bone marrow function must be normal. There must be no history of cardiac disease, and the baseline MUGA and/or echocardiogram should demonstrate normal left ventricular function. Expected Enrollment If there are any responses among the first 14 patients entered, accrual will continue until at least 25 evaluable patients have been entered. Outline Nonrandomized study. Single-agent Chemotherapy. 4'-Deoxydoxorubicin, NSC-267469.Published Results Kish JA, Ensley JF, al-Sarraf M: Phase II evaluation of 4'deoxydoxorubicin in advanced renal cell carcinoma. Am J Clin Oncol 13 (1): 17-8, 1990.[PUBMED Abstract] Trial Lead Organizations Barbara Ann Karmanos Cancer Institute
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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