Role of salvage chemotherapy with topotecan and cisplatin in patients with paclitaxel- and platinum-resistant recurrent ovarian or primary peritoneal cancer: A phase II pilot study

Background and Objectives: We assessed the role of salvage chemotherapy with topotecan and cisplatin in patients with platinum- and paclitaxel- resistant advanced and recurrent ovarian or primary peritoneal cancer, based on the reported in vivo and in vitro synergism between these two drugs. Methods: Twenty patients were entered in this phase II trial from November 1997 to November 1998. They received cisplatin at 50 mg/m² on day 1 with topotecan at 0.6 mg/m² from day 1 to 5 every 28 days. In 70% of patients (14/20), this combination represented at least a third line of therapy. Results: A clinical response rate of 13.3% (two partial responses) was obtained in the 15 patients with evaluable disease. Sixty percent of patients (9/15) had stable disease and 26.7% (4/15) had progression. The median progression-free interval and survival were 4 months and 7 months, respectively. The 20 patients evaluable for toxicity received a mean of four chemotherapy cycles. Dose reductions were required in 45% of patients despite the administration of growth factors. The major dose-limiting toxicity was 50% occurrence (10/20) of grade 4 thrombocytopenia and 30% (6/20) grade 4 neutropenia. There was one septic death. Conclusions: These data suggest that combination therapy with topotecan and cisplatin has minimal activity in platinum- and paclitaxel-resistant advanced and recurrent ovarian or primary peritoneal cancer at the doses utilized in this trial.