Phase I/II study of CPT-11 plus S-1 in patients with advanced gastric cancer

4191 Background: We reported the results of phase I study part of the treatment with CPT-11 (irinotecan) and S-1, a new oral fluoropyrimidine, in gastric cancer patients at ASCO 2002. This paper reports Phase II study part using the previously defined recommended dose, including results of median survival time (MST). Methods: A combined treatment of CPT-11 and S-1 was performed in patients with inoperable advanced gastric cancer who had not received a prior chemotherapy. S-1 was orally administered twice a day for 14 consecutive days, and CPT-11 was administered as a 90-minute intravenous infusion on days 1 and 15. This schedule was repeated every 4 weeks. The patients received 80 mg/m2 /day dose of S-1 and 125 mg/m2 of CPT-11 recommended from phase I study. Results: Fifteen patients were registered in this Phase I study. And 9 patients were added in this Phase II study. Non-hematological toxicities were almost classified as grade 2 or lower, except for grade 3 nausea and grade 3 dermatitis at level 2. Th...