Background/aims: Topotecan and docetaxel are active agents in the treatment of various malignant diseases. Both drugs cause dose-limiting hematologic toxicity. This study defines the maximum tolerated dose (MTD) and dose-limiting toxicity of weekly topotecan when administered in combination with docetaxel 25 mg/m(2) given day 1, 8,15 every 28 days.
Methods: Thirteen patients were enrolled. Median age was 62 years. Majority of the patients had lung cancer.
Results: The maximum tolerated dose was docetaxel 25 mg/m(2) and topotecan 3 mg/m(2) administered weekly. Dose-limiting toxicity was febrile neutropenia. Eight patients developed at least grade 3 neutropenia in all cycles. Non-hematologic toxicities were mild. No objective responses were noted. Two patients with non-small cell lung cancer had stable disease as a best response.
Conclusion: Combination docetaxel and topotecan given weekly is tolerable. The recommended phase II dose is docetaxel 25 mg/m(2) and topotecan 3 mg/m(2) day 1, 8, 15 every 28 days.