Phase I-II study of irinotecan in combination with mitomycin C in patientswith advanced gastrointestinal cancer

This phase I-II study was conducted to determine the maximum tolerated dose and optimal schedule of a combination of irinotecan (CPT 11) and mitomycin C (MMC) in a population of previously treated patients with gastrointestin al malignancies. Four cohorts of patients were recruited with MMC given at 8 mg/m(2) for the first 3 levels together with irinotecan at 300 mg/m(2), 3 25 mg/m(2), and 350 mg/m(2); the fourth dose level was given with MMC at 10 mg/m(2) and irinotecan at 325 mg/m(2). All treatment was repeated at 21-da y intervals. The dose-limiting toxicity was hematologic (thrombocytopenia a t level 4), and the recommended doses for subsequent phase II studies are M MC 8 mg/m(2) with irinotecan 325 mg/m(2). Evidence of efficacy was seen at all dose levels examined and justifies further exploration of this combinat ion in a less heavily pretreated patient population.