A Phase II Study of Gemcitabine Plus Cisplatin in Previously Untreated Advanced Ovarian Cancer

Abstract

Background: The primary objective was the evaluation of the effects of gemcitabine plus cisplatin on the overall response rate (ORR) of patients with advanced ovarian cancer; the secondary assessments included toxicity, time to progressive disease (TtPD) and the duration of response. Materials and Methods: Chemonaive patients with stage III/IV ovarian cancer received gemcitabine 1250 mg/m² (d 1,8) and cisplatin 75 mg/m² (d 1), every 21 days for a maximum of six cycles. Results: Between March 1999 and June 2003, 28 patients (median age 52 years, range 23-72) had received chemotherapy. Of 26 assessable patients, the ORR was 57.7% (95% CI, 42.7%-83.6%) based on four complete responses and eleven partial responses, six patients experienced stable disease, while five had progressive disease. The median survival was 28.1 months (95% CI, 11.4-33.4 months), the median TtPD was 10.5 months (95% CI, 1.4-44.2 months) and the median duration of response was 24.3 months (95% CI, 12.3-33.4 months). The most common grade 3/4 toxicities were nausea/vomiting (15.2%) and neutropenia (10.7%). There was no grade 3 or 4 thrombocytopenia. Conclusion: Gemcitabine plus cisplatin exhibited activity in advanced ovarian cancer with an acceptable toxicity profile.