PURPOSE: FP(5-FU, Cisplatin) combination is one of the most active regimen for the advanced gastric cancer with a response rate of 50~60%. In spite of this high response rate, there is little evidence that FP regimen results in survival benefit for patients with advanced gastric cancer. This study was performed to evaluate the efficacy and toxicity of this regimen with the addition of levamisole, an immunomodulatory agent, known as enhancing the antitumor effects of 5-FU in other cancer. MATERIALS AND METHODS: Previously untreated patients with metastatic or recurrent gastric cancer were treated with 5-FU(1000 mg/M2 civ, D1~5), cisplatin(60 mg/M2 iv, Dl) every 3 weeks, and levamisole(150 mg/day, Dl~3) every 2 weeks. The major endpoints were response rate, response duration, and toxicities. RESULTS: Between June 1992 and Aug. 1996, thirty three patients were included in this study. Patients received 2~18 cycles of chemotherapy(median 5). Among the evaluable 31 patients, 18 patients(58%, 95% C.I. 40.4~75.7) showed objective responses including one(3.2%) clinical complete response. The median response duration was 7.7 months(95% C.I. 3.6~11.8). During total of 189 cycles of chemotherapy, 79 episodes(41.7%) of leucopenia were observed. There was no death from concurrent infection. CONCLUSION: FPL combination therapy is at least as effective as conventional FP chemotherapy, but resulted in somewhat more myelosuppression.