A phase II study of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine and ovarian cancers

Objectives. A phase II trial designed to evaluate the safety and efficacy of weekly topotecan and docetaxel in heavily treated patients with recurrent uterine or epithelial ovarian cancers. Methods. Eligible patients with recurrent epithelial ovarian or uterine cancers were treated with weekly topotecan 3.5 mg/m(2) and docetaxel 30 mg/m(2) for 3 consecutive weeks. Cycles were repeated every 4 weeks for 6 cycles OF until evidence of disease progression, unacceptable toxicity, or death. Response was assessed as per RECIST or Rustin's criteria. Time to best response and overall survival were calculated using Kaplan-Meier statistical methods. Results. Twenty-seven patients registered, of which 24 were evaluable for response. The majority of patients had received 2 prior chemotherapy regimens. Of the total 86 cycles of chemotherapy that were administered, there were three grade 4 (all neutropenia) and ten grade 3 toxicities. Six of the grade 3 non-hematologic toxicities were unrelated to treatment. There were 8 dose delays and 4 dose reductions. The overall response rate was 25% (95% Cl: 7.7%-42.3%, 8% CR, 17% PR), and 38% of the patients had clinical benefit (95% Cl: 18.1%-56.9%; CR+ PR+ 13% SD). The median duration of response was 8.5 months (range 3-19 months). The median overall survival was 18.5 months (range 1.8-50.7 months). Conclusion. The combination of weekly topotecan and docetaxel has clinical benefit and is well tolerated in this heavily treated patient population. Patients with platinum-resistant tumors had clinical benefit and should be considered for further Study with this regimen. (C) 2009 Elsevier Inc. All rights reserved.