A phase II study of gemcitabine (gemzar, LY188011) in the treatment of recurrent or persistent endometrial carcinoma: A gynecologic oncology group study

Objective: The study aims to evaluate the anti-tumor activity and toxicity of gemcitabine in patients with persistent or recurrent endometrial carcinoma. Methods: Patients with advanced or recurrent carcinoma of the endometrium previously treated with one chemotherapy regimen were treated on a phase II trial conducted by the Gynecologic Oncology Group (GOG). Gemcitabine was administered as an intravenous infusion at a dose of 800 mg/m² over 30 min on days 1 and 8 every 21 days. Results: Twenty-four patients were entered by 11 GOG member institutions. One patient was ineligible due to wrong primary tumor. A total of ninety 21-day cycles of therapy were administered with 35% of patients receiving four or more cycles. All patients had been previously treated with a platinum-based regimen. One patient had a partial response (4%), nine had stable disease (39%), and twelve had increasing disease (52%). The median progression-free survival was 1.7 months. Treatment was generally well tolerated with only 22% of patients experiencing grade 3 or grade 4 hematologic toxicity. There was one treated-related death due to pulmonary toxicity. Conclusion: Gemcitabine has minimal activity in the treatment of recurrent or persistent endometrial carcinoma at the dose and schedule tested.