Phase II study of topotecan (NSC 609 699) in patients with recurrent or metastatic soft tissue sarcoma.

BACKGROUND: New drugs are needed for treatment of unresectable or metastatic soft tissue sarcoma. Topotecan, a semisynthetic derivative of the alkaloid, camptothecin, exerts its cytotoxic effect through inhibition of topoisomerase I. PATIENTS AND METHODS: Thirty-two adult patients with locally advanced or metastatic soft tissue sarcoma entered this phase II study of topotecan, administered at 1.5 mg/m2/day IV x 5 days every 3 weeks. All had measurable disease and none had received previous chemotherapy.
RESULTS: There were 3 partial responses (10.3%; 95% CI 2.2-27.4%) in 29 evaluable patients. Grade 3 or 4 neutropenia occurred in 25 patients, and there was a 17% incidence of infection/neutropenic fever leading to one toxic death.
CONCLUSIONS: Topotecan, in this dose and schedule, has low activity in adult soft tissue sarcoma.

RCT Entities:   Population Interventions Outcomes