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A phase-I study of cpt-11, weekly bolus 5-fu and leucovorin in patients with metastatic cancer.

CPT-11 is a topoisomerase I inhibitor with activity against colorectal cancer. This study was designed to explore the potential for combining CPT-11 with fluorouracil and leucovorin. 5-FU (500 mg/m(2)) and leucovorin (500 mg/m(2)) were administered for 4 consecutive weeks and CPT-11 was given on weeks 1 and 4 of each 6 week cycle. The starting dose of CPT-11 was 25 mg/m(2) and the dosage was escalated by increments of 25 mg/m(2) in cohorts of 3 patients. Nine patients were treated on study. Grade 4 diarrhea was the dose limiting toxicity at 50 mg/m(2). Alternative strategies to combine CPT-11 with 5-FU and leucovorin are being explored.