Phase II study of paclitaxel with 3-h infusion in patients with advanced gastric cancer

Publisher Website
Google Scholar
Abstract
To increase the options for agents for gastric cancer chemotherapy, we performed a phase II clinical trial on the use of a 3-h infusion of paclitaxel to confirm its efficacy and the feasibility of its use in patients with advanced gastric cancer. Thirty-two (32) patients with measurable metastatic gastric cancer were enrolled in this study. Seventeen patients (53%) had received prior chemotherapy for metastatic disease, 4 patients (13%) had adjuvant chemotherapy alone, and 11 patients (34%) were chemotherapy-naive. Paclitaxel was intravenously infused for 3 h, at a dose of 210 mg/m2, once every 3 weeks. To prevent hypersensitivity reactions, standard premedication was administered to all patients. Nine (28%; 9/32 ) objective partial responses (PRs) were observed (95% confidence interval [CI], 14%–47%), and the remaining 23 patients showed stable (12 patients; 37.5%) and progressive disease (11 patients; 34.4%). The median time to response was 20 days (range, 14–38 days). The median response duration was 87 days (range, 50–103 days). The median survival of all patients was 234 days (range, 13–646+ days). The major adverse reactions were myelosuppression (grade 3/4 leukopenia and neutropenia were observed in 59% and 88% of the patients, respectively), alopecia, and peripheral neuropathy. Peripheral neuropathy was observed in 19 patients, however, most of the patients recovered after the completion of treatment. A 3-h infusion of paclitaxel is an effective therapy for advanced gastric cancer and is clinically well tolerated by the patients.

This publication has 0 references indexed in Scilit: