Randomized phase II study comparing dose escalated weekly paclitaxel vs. standard dose weekly paclitaxel for patients...

Weekly paclitaxel is an effective and widely used regimen for patients with advanced gastric cancer, with main dose-limiting toxicities of neutropenia and neurotoxicity. Neutropenia during weekly paclitaxel administration was reported to be associated with better survival. The aim of this study is to evaluate prospectively whether dosing adjustments based on the occurrence of neutropenia may improve chemotherapy efficacy. A total of 90 patients will be randomized to receive either a standard dose of weekly paclitaxel (80 mg/m(2)) or an escalated dose of weekly paclitaxel (80 mg/m(2) initially followed by 100 and 120 mg/m(2) unless severe toxicity is observed). The primary endpoint is overall survival. Secondary endpoints include progression-free survival, response rate, disease control rate and adverse events.