Phase II study of weekly paclitaxel by one-hour infusion for advanced gastric cancer

Purpose. A phase clinical II trial was conducted to determine the antitumor activity and toxicity of weekly paclitaxel administered to patients with advanced gastric cancer. Methods. Sixty-eight patients with advanced gastric cancer and performance status 0-2 were treated with 80 mg/m² paclitaxel over 1 h following a short course of premedication with dexamethasone, diphenhydramine, and ranitidine administered 30 min prior to the delivery of the paclitaxel. In principle, the treatment was repeated weekly for three courses, followed by a 1-week rest. Results. Objective responses were observed in 12 of 68 patients (17.6%; 95% confidence interval: 9.5%-28.8%). Two of fourteen (14.2%) patients with no prior chemotherapy and 10 of 54 (18.5%) patients previously treated for metastatic disease developed a partial response. The median therapeutic duration and the median survival time were 96 days and 222 days, respectively. In 212 (85.5%) of 248 total cycles, the original dose of 80 mg/m² of paclitaxel was administered and was well tolerated. Fourteen of 68 patients (20.1%) experienced grade 3 or 4 neutropenia. Grade 1 or 2 peripheral neuropathy occurred in 10 patients (14.7%). Conclusion. Weekly paclitaxel therapy is an active and safe treatment for advanced gastric cancer.