A phase II study of gemcitabine plus cisplatin in previously untreated advanced ovarian cancer

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/m(2) (d 1,8) and cisplatin 75 mg/m(2) (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 314 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.