A phase II study of docetaxel and cisplatin in patients with gastric cancer recurring after or progressing during 5-FU/platinum treatment

Background: Docetaxel plus cisplatin (DP) is a combination chemotherapy regimen that is active against untreated advanced gastric cancer. We evaluated the feasibility of DP treatment in patients with recurring or metastatic gastric cancer who had been previously treated with other chemotherapy regimens. Patients and methods: The DP regimen consisted of doxetaxel (75 mg/m(2) i.v.). and cisplatin (60 mg/m(2) i.v.) over 1 h on Day 1 every 4 weeks for a maximum of nine cycles. Results: Thirty-seven patients (28 men, 9 women; median age, 53 years; range 28-71 years) received a total of 128 cycles of therapy (median, 3; range 1-9). Twenty-six patients had recurrent disease and 11 had metastatic tumors. The objective response rate was 32.4% (95% confidence interval = 16.6-48.3%), including 1 complete response and 11 partial responses. Eleven had stable disease, whereas 12 had progressive disease. The median duration of response was 70.5 days (range 30-392 days). Grade 3/4 toxicities included anemia (10.8%), leukopenia (27.0%), neutropenia (51.4%), thrombocytopenia (2.7%), nausea/vomiting (5.4%) and oral mucositis (13.5%). Median time to progression was 136 days and median overall survival was 235 days. Conclusion: The DP combination was well tolerated and effective for patients with metastatic gastric cancer treated previously with 5-fluorouracil/platinum chemotherapy.