A phase II evaluation of pemetrexed (ALIMTA, LY231514, IND#40061) in the treatment of recurrent or persistent endometrial carcinoma: A phase II study of the Gynecologic Oncology Group

e16507 Background: To estimate the anti-tumor activity of pemetrexed in patients with advanced or recurrent carcinoma of the endometrium that failed on higher priority treatment protocols and to determine the nature and degree of toxicity. Methods: A multicenter phase II trial was conducted by the Gynecologic Oncology Group (GOG). Patients must have had advanced or recurrent measurable carcinoma of the endometrium and failed one prior chemotherapy regimen. Pemetrexed at a dose of 900 mg/m2 was to be administered as an IV infusion over 10 minutes every 21 days. Results: From May 1, 2006 to July 31, 2007, 27 patients were entered by ten member institutions of the GOG. A total of 101 cycles were administered with 27% of patients receiving five or more cycles. The treatment was well tolerated overall. More serious toxicities (grade 3 and 4) included anemia in 19%, leukopenia in 38%, neutropenia in 46%, and constitutional in 19%. No treatment related deaths were reported. One patient (4%) had a partial respons...