A phase I study of bi-weekly docetaxel for recurrent or advanced gastric cancer patients whose disease progressed by prior chemotherapy.

OBJECTIVE: Although docetaxel is active against gastric cancer, Grade 3 or 4 neutropenia occurs in the majority of patients in Japan when administered at 60 mg/m(2) every 3 weeks. To determine a more convenient and tolerable schedule than the tri-weekly schedule, we conducted a dose-escalation study of bi-weekly docetaxel. In this study, we investigated the maximum-tolerated dose and recommended dose.

METHODS: Patients with advanced gastric cancer who had received prior chemotherapy were enrolled between April 2004 and March 2007. This study was designed to evaluate the escalated dose of docetaxel starting at 35 mg/m(2) (Level 1) given every 2 weeks. The dose was escalated in a stepwise fashion to 40 mg/m(2) (Level 2), 45 mg/m(2) (Level 3) and 50 mg/m(2) (Level 4).

RESULTS: Fifteen patients completed at least two cycles of the therapy. Three episodes of Grade 3 neutropenia occurred in all patients and Grade 4 neutropenia was observed at Level 4 in six patients. Grade 3 or 4 thrombocytopenia and anemia were not observed. Grade 3 aspartate aminotransferase/alanine aminotransferase elevation (n= 1) and Grade 3 stomatitis (n = 1) were noted at Level 4. There was no other Grade 3 or 4 non-hematologic toxicity. The definition of dose-limiting toxicities of this docetaxel schedule at Level 4 are Grade 4 neutropenia, Grade 3 aspartate aminotransferase/alanine aminotransferase elevation and Grade 3 stomatitis.

CONCLUSIONS: The maximum-tolerated dose of docetaxel when administrated following the bi-weekly schedule was 50 mg/m(2) and the recommended dose was 45 mg/m(2). Bi-weekly administration of docetaxel may provide a better tolerated and efficacious use in gastric cancer.