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Phase III Chemotherapy with FAM-S(5-FU/ADR/MITO/SZC) vs Phase II Chemotherapy with Dihydroxyanthracenedione for Advanced Adenocarcinoma of the Pancreas
Basic Trial Information
Objectives I. Determine the antitumor activity of DHAD, as determined by response rate and duration of response, given on a single-dose every-three-weeks schedule in patients with advanced adenocarcinoma of the pancreas. II. Determine additional information concerning the nature and degree of toxicity of this drug. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with histologically confirmed adenocarcinoma of the exocrine pancreas with distant metastases (liver, peritoneum, etc.) or with localized disease not amenable to curative surgery or radiotherapy. There must be objectively measurable disease. Patients must be under 70 years of age and have a life expectancy of at least 10 weeks. The performance status must be at worst Grade 3 by SWOG criteria; hematologic and renal function must be adequate. Patients may not have received prior chemotherapy or radiotherapy. Therapy on this protocol should begin not less than 3 weeks after any prior surgery. (Per Addendum 1, July 1981, patients whose cumulative dose of prior adriamycin exceeds 400 mg/sqm are ineligible, and cardiac monitoring must be done in those who have received a prior total dose of 350 mg/sqm; ejection fractions must be within normal limits. A past history of heart disease is cause for exclusion.) This protocol is Appendix VII of SWOG-8040 (master protocol). DHAD is the second Phase II agent to be evaluated on this master study. Expected Enrollment 25 patients will be treated on the arm described in this protocol. The DHAD arm closed temporarily in May 1983 for evaluation of data; there is a possibility it will be reopened. Protocol permanently closed August 1984. Outline Randomized study. Arm I: 4-Drug Combination Chemotherapy with FAM-S. See SWOG-8040. Arm II: Single-agent Chemotherapy. Dihydroxyanthracenedione, DHAD, NSC-301739.Published Results Bukowski RM, Fleming TR, Macdonald JS, et al.: Evaluation of combination chemotherapy and phase II agents in pancreatic adenocarcinoma. A Southwest Oncology Group study. Cancer 71 (2): 322-5, 1993.[PUBMED Abstract] Taylor SA, Fleming T, Von Hoff DD, et al.: Phase II evaluation of mitoxantrone in advanced pancreatic carcinoma: a Southwest Oncology Group study. Invest New Drugs 8 (1): 77-80, 1990.[PUBMED Abstract] Bukowski RM, Inamasu M, Taylor S, et al.: Randomized trial of combination chemotherapy vs. a phase II drug in metastatic adenocarcinoma of the pancreas: Southwest Oncology Group study. [Abstract] Proceedings of the American Society of Clinical Oncology 4: C-311, 80, 1985. Trial Lead Organizations Southwest 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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