Phase II study of single-agent gemcitabine in heavily pretreated Japanese patients with recurrent ovarian cancer.

Background: Gemcitabine has been recommended as an active agent for salvage chemotherapy in patients with recurrent epithelial ovarian cancer, but no clinical study of this agent has been conducted for Japanese women with ovarian cancer. To evaluate the efficacy and feasibility of gemcitabine for heavily pretreated Japanese patients with recurrent epithelial ovarian cancer, we conducted a single-institute phase II clinical trial.

Methods: All patients had received a minimum of two previous chemotherapy regimens, In this study, gemcitabine was administered at 1000 mg/m(2) on days 1, 8, and 15 of a 28-day cycle.

Results: A total of 28 patients participated in this study. Although 5 patients (17.9%) needed dose reduction to 800 mg/m(2) because of thrombocytopenia and granulocytopenia, all patients completed an average of 6.7 courses (range, 2-24 courses). The overall response rate, including five partial responses, was 17.9% (95% confidence interval [C I], 6.0-36.9). The median time to progression was 8.8 months and the median survival period was 11.2 months. Grade 3/4 hematological toxicities included leucopenia, 35.7%; granulocytopenia, 39.3%; anemia, 46.4%; and thrombocytopenia, 10.7%. However, no grade 3/4 nonhematological toxicity was observed. The mean delay in treatment was 5.0 +/- 7.7 days (range, 0-15 days) in a total of 562 cycles.

Conclusion: Single-agent gemcitabine is an effective salvage chemotherapy regimen in heavily pretreated Japanese patients with recurrent epithelial ovarian cancer.