A phase II study of weekly docetaxel as salvage chemotherapy for advanced gastric cancer

Background: Docetaxel has shown some activity in advanced gastric cancer. R ecent phase I studies found low hematologic toxicity and a favourable toxic ity profile when docetaxel was administered on a weekly schedule. In this s tudy, we explored the activity of weekly docetaxel in patients with advance d gastric cancer who failed first-line chemotherapy. Materials and methods: Patients with stable or progressing disease after fi rst-line chemotherapy received 36 mg/m(2) weekly docetaxel. One cycle consi sted of six administrations followed by a two-weeks rest, patients were re- evaluated at week eight. The optimal two-stage design was adopted for early stopping of the trial if responses were one or less in 21 patients (< 20% response rate with alpha and beta error probabilities 0.05 and 0.010 respec tively). Results: Twenty-one patients have been enrolled and they are fully evaluabl e for response and toxicity. One patient achieved partial response, 8 patie nts had stable disease and 12 patients progressed. Median overall survival from the onset of salvage chemotherapy was 3.5 months. Hematologic toxicity was observed in two patients who experienced grade III leukopenia. Beginni ng from the third week of treatment, most of the patients (90%) showed grad e II asthenia which resulted the commonest side-effect. Conclusions: This schedule of weekly docetaxel did not show significant act ivity in pretreated patients with advanced gastric cancer.