Phase II trial of gemcitabine in patients with advanced gastric cancer.

Overview

BACKGROUND: Approximately 22,000 new cases of gastric cancer are diagnosed each year in the United States, most of which are advanced disease and thus are not curable by surgery. Chemotherapy has had little impact on patient survival. Consequently, the evaluation of new agents is needed. Gemcitabine, a cytosine arabinoside analogue, was evaluated in a Phase II trial to assess its efficacy in previously untreated patients with advanced gastric cancer. METHODS: Patients were treated with weekly gemcitabine, 800 mg/m2, for 3 consecutive weeks, followed by a 1-week rest period. Eighteen patients were enrolled. Fifteen patients were evaluable for response; 2 patients refused therapy before the completion of one cycle of treatment, and one patient was found to have nonmeasurable disease. RESULTS: No major objective responses were seen. Two minor responses occurred. One patient with a minor response was removed from the study at his request after ten cycles of treatment. The other patient remains on the study with stable disease at more than 17 months. Toxicities on this study were mild. Median leukocyte count and platelet nadirs were 5.0 (range, 2.2-51.0) and 234,000/microliters (range, 59,000-554,000/microliters), respectively. CONCLUSION: Gemcitabine at this dose and schedule has no significant antitumor activity in gastric cancer.