A phase I study of biweekly docetaxel as salvage chemotherapy in advanced gastric cancer.

Abstract

e14607 Background: Docetaxel is active for gastric cancer. However, grade 4 neutropenia occurs in the majority of patients with a dose of 60 mg/m2 every 3 weeks in Japan. To find a more convenient and tolerable schedule than the triweekly schedule, we conducted a dose escalation study of biweekly docetaxel. This dose escalation study investigated the maximal tolerated dose (MTD) and the recommended dose (RD). Methods: Patients with advanced gastric cancer who had received more than one prior chemotherapy regimen were enrolled between April 2004 and March 2007. This study was designed to evaluate escalated dose of docetaxel starting at 35 mg/m2 (level 1) (n = 3) given every two weeks. The dose was escalated to 40 mg/m2 (level 2) (n = 3), 45 mg/m2 (level 3) (n = 3) and 50 mg/m2 (level 4) (n = 6) in a stepwise fashion. Results: Fifteen patients completed at least two cycles of therapy. Three episodes of grade 3 neutropenia occurred in all patients and grade 4 neutropenia was seen at dose level 4 in all 6 patients. No grade 3 or 4 thrombocytopenia and anemia was observed. Grade 3 AST/ALT elevation (n = 1) and grade 3 stomatitis (n = 1) were noted at level 4. No other grade 3 or 4 nonhematologic toxicity was observed. The definition of dose-limiting toxicities of this docetaxel schedule are grade 4 neutropenia, grade 3 AST/ALT elevation and grade 3 stomatitis at level 4. Conclusions: The MTD of docetaxel when administrated by this biweekly schedule was 50 mg/m2 and the RD was 45 mg/m2. Biweekly administration of docetaxel may provide a better tolerated and efficacious use of this drug. Phase II study of this regimen is underway. No significant financial relationships to disclose.