Phase II trial of outpatient schedule of paclitaxel in patients with previously untreated metastatic, measurable adenocarcinoma of the stomach

Background: Chemotherapy represents the standard treatment for patients with metastatic stomach cancer. Conflicting results have been published regarding the activity of paclitaxel in this setting. Therefore, we developed a phase II study to evaluate an outpatient 3 h infusion of paclitaxel. Methods: Patients with chemonaive metastatic stomach cancer received paclitaxel 210 mg/m(2) every 3 weeks. Patients with esophageal cancer were not eligible. Results: Twenty-one patients were enrolled. The median age was 55.5 years (range 37-81 years). Two partial responses were observed among the 18 patients evaluable for response and toxicity (response rate 11%, 95% CI: 2-33%). The median time to progression was 10.5 weeks and median survival 23 weeks. There was only one episode of grade IV neutropenia and no episodes of grade 3-4 non-hematological toxicity were observed. Conclusion: Paclitaxel exhibited minimal activity in this patient population.