A phase II trial of paclitaxel, 5-fluorouracil (5-FU) and cisplatin in patients with metastatic or recurrent gastric cancer.

Objective: We wanted to assess the effectiveness and safety of combination chemotherapy with paclitaxel, 5-fluorouracil (5-FU) and cisplatin for treating advanced gastric cancer.

Methods: Patients with metastatic or recurrent gastric cancer were entered into this study. Paclitaxel at a dose of 135 mg/m(2) on day 1, 5-FU 1 g/m(2)/day in a 24 hour continuous infusion from day 1 to day 4 and cisplatin 60 mg/m(2) on day 1 were administered. This regimen was repeated every 3 weeks.

Results: A total of 34 patients were enrolled in this study. Among them, 33 patients were finally evaluable for their response. 17 (51.5%) patients had a partial response (95% CI: 26.0 approximately 77.0%). The median duration of overall survival was 13.2 months. Grade 3 or 4 neutropenia and thrombocytopenia were observed in 15.2% and 1.1% of all the cycles, respectively. Grade 3 stomatitis and neurotoxicity were observed in 20.6% and 1.1% of all patients, respectively. Grade 4 non-hematologic toxicity was not observed.

Conclusions: The regimen of paclitaxel, 5-FU and cisplatin demonstrated activity and acceptable toxicity for treating metastatic gastric cancer.