Phase I/II study of 24-hour infusion of irinotecan combined with oral UFT for metastatic colorectal cancer

Background: To evaluate the efficacy and safety of irinotecan combined with UFT for untreated and pretreated metastatic colorectal cancer. Methods: Escalating doses of irinotecan (80-110 mg/m(2)) were administered by 24-hour infusion on day 1. UFT was administered orally at 400 mg/m(2)/day on days 3-7 and 10-14. The treatment cycles were repeated every 2 weeks. Results: In the phase I study, the maximum tolerated dose of irinotecan was 110 mg/m(2) and the recommended dose for the phase II study was determined to be 100 mg/m(2). Thirty-five patients including 3 patients at the recommended dose in the phase I study were evaluated in the phase II study. The grade 3/4 toxicities observed were leukopenia, neutropenia, thrombocytopenia and anemia. No grade 3 or more severe nonhematological toxicities were noted. The response rate was 62.9% and the median overall survival 16.7 months. Conclusions: A 24-hour infusion of irinotecan combined with UFT is feasible and active for metastatic colorectal cancer. Copyright (c) 2008 S. Karger AG, Basel.