Phase II trial of topotecan by continuous infusion in patients with advanced soft tissue sarcomas, a SWOG study. Southwest Oncology Group.

Based upon the hypothesis that prolonged exposure to the S-Phase specific agent topotecan would be more efficacious in the treatment of soft tissue sarcomas than a conventional 5-day schedule of the drug, the Southwest Oncology Group performed a Phase II trial of topotecan administered as a continuous infusion in adult patients with advanced soft tissue sarcomas. Patients who had received no prior chemotherapy for advanced disease were treated with topotecan at a dose of 0.50 mg/m2/day on days 1-21 of repeated 28 day cycles. Twenty-two patients were enrolled on the study, of whom 21 were eligible. No objective responses were observed (95% confidence interval of 0-16%). The median survival was 12 months (95% confidence interval of 5-16 months). We conclude that topotecan, given either according to a 5-day or a 21-day schedule, has minimal activity in the treatment of adult soft tissue sarcomas.