Irinotecan plus cisplatin combination against metastatic gastric cancer: phase II study.

In this phase II study, we aimed to detect efficacy and toxicity of the combination of CPT-11 and cisplatin administered to patients with metastatic gastric carcinoma. On d 1, CPT-11, 100 mg/m2, was administered by intravenous infusion for 90 min, followed by a 2 h infusion of cisplatin, at 70 mg/m2 every 3 wk. Forty-one patients were enrolled into the study. Twenty-eight patients were chemotherapy naive. The total number of chemotherapy cycles administered was 165, and the median number of cycles received was 4 (range, 1-8 cycles). The median follow-up time was 12 mo (range, 4-34 mo). There were 4 complete responses (9.7%) and 14 partial responses (34.2%), which result in a response rate of 43.9% (18 of 41 patients). The median time to progression was 8.0 +/- 0.8 mo with 56% and 13% of patients progression free at 6 and 12 mo, respectively. The median overall survival was 9.0 +/- 1.1 mo, with 68 % and 32% of patients alive at 6 and 12 mo, respectively. Grade 3-4 nausea and vomiting was observed in five patients (12%) and grade 3-4 neutropenia in five patients (12%). Grade 3 infection was observed in only one patient (2%). Grade 2 transient liver dysfunction related to chemotherapy was observed in one patient (2%). Chemotherapy was stopped due to nephrotoxicity in one patient (2%). There was no treatment-related death. In conclusion, administration of CPT-11 and cisplatin in this particular dose every 3 wk is effective and well-tolerated treatment regimen.