Topotecan and gemcitabine in platinum/paclitaxel-resistant ovarian cancer

24 patients were enrolled into a phase I-II study conducted to determine th e maximum tolerated doses of topotecan-gemcitabine in sequential combinatio n and the response rate in platinum/paclitaxel resistant ovarian cancer pat ients. A total of 83 courses are evaluable, with a median number of three c ycles administered per patients (range 2-7). Topotecan was administered on days 1-5 by 30 min i.v. infusion immediately after gemcitabine given by 30 min i.v. on days 1 and 3; cycles were repeated every 28 days. The starting doses were topotecan 0.7 mg/m(2) and gemcitabine 200 mg/m(2). Following dos e levels were 08/400; 0.9/600; 0.9/800 for topotecan and gemcitabine, respe ctively. The maximum tolerated dose (MTD) was reached at dose level 3, the dose-limiting toxicity being represented by febrile neutropenia and thrombo cytopenia. After the MTD was reached, granulocyte-colony-stimulating factor was administered in 27% of cycles. Mild and manageable was non hematologic al toxicity. All patients are so far evaluable for response. Among them 2 c omplete responses (8.3%; 95% CI: 2.6-19), 1 partial response (4.2%; 95% CI: 3.8-12), 9 no change (37.5%; 95% CI: 18-56.8) and 12 progressions (50%; 95 % CI: 30-70) have been registered. Based on these data, there is no evidenc e that combining topotecan and gemcitabine is better than using either of t he two drugs used separately Copyright (C) 2001 S. Karger AG, Basel.