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Phase I/II Evaluation of ANG Modification of 5-FU and MITO Toxicity for Unresectable Colorectal and Refractory Gastric Cancer
Basic Trial Information
Objectives I. Evaluate whether pretreatment with anguidine can induce preferential cytostasis in normal host tissue and thereby permit administration of higher doses of 5-fluorouracil and mitomycin-C in patients with gastrointestinal malignancies. II. Determine incidence and duration of response and survival following front-line treatment with anguidine and 5-fluorouracil or mitomycin-C in patients with colorectal cancer and salvage therapy with the same agents in patients with gastric cancer. III. Determine the associated acute and chronic toxicities of this program, particularly modification of the well-known toxicities of 5-fluorouracil and mitomycin-C, after pretreatment with anguidine. IV. Combine all three agents once the beneficial effects of anguidine pretreatment for both 5-fluorouracil and mitomycin-C administered singly have been established. Entry Criteria Disease Characteristics: See General Eligibility Criteria Patient Characteristics: See General Eligibility Criteria General Eligibility Criteria: Patients with biopsy-proven, unresectable colorectal carcinoma. Patients with refractory gastric carcinoma are eligible for salvage therapy. Measurable disease is preferred, but evaluable disease is acceptable. Patients must have a life expectancy of at least 3 months and adequate bone marrow (granulocytes greater than 1,500/microliter and platelets greater than 100,000/microliter) and renal (creatinine at most 2.0 mg/dl) function. Prior 5-fluorouracil or mitomycin-C is allowed, provided that (1) treatment was given as adjuvant chemotherapy by intravenous or hepatic arterial infusion with a treatment-free interval of at least 2 years; or (2) treatment was given by hepatic arterial infusion for initially localized metastatic disease; or (3) at most two courses of 5-fluorouracil or mitomycin-C were given for metastatic disease without disease progression. Expected Enrollment A minimum of 28 evaluable patients (14 per arm) will be required. Protocol closed to patient entry in April 1983. Outline Randomized study. Arm I: 2-Drug Combination Chemotherapy. Anguidine, ANG, NSC-141537; 5-Fluorouracil, 5-FU, NSC-19893. Arm II: 2-Drug Combination Chemotherapy. ANG; Mitomycin-C, MITO, NSC-26980. Trial Lead Organizations M. D. Anderson Cancer Center at University of Texas
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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