Evaluation of pemetrexed (Alimta, LY231514) as second line chemotherapy in persistent or recurrent carcinoma of the cervix: A Phase II study of the Gynecologic Oncology Group

Objective. To estimate the anti-tumor activity of pemetrexed in patients with advanced or recurrent carcinoma of the cervix 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 cervix, and failed one prior chemotherapy regimen. Pemetrexed at a dose of 900 mg/m2 was to be administered as an IV infusion over 10 min every 21 days.Results. From July 6, 2004 to April 3, 2006, twenty-nine patients were entered by ten member institutions of the GOG. Two patients did not receive treatment and thus were inevaluable. A total of 128 cycles were administered with 37% of patients receiving six or more cycles. The treatment was well tolerated overall. More serious toxicities (grade 3 and 4) included anemia in 41%, leukopenia in 30%, neutropenia in 26%, and infection in 26%. No treatment related deaths were reported. Four patients (15%) had partial responses with a median response duration of 4.4 months. The response rate for non-radiated or radiated disease sites was 25% and 7% respectively. Sixteen patients (59%) had stable disease and seven (26%) patients had increasing disease. Median progression free survival (PFS) was 3.1 months and overall survival (OS) was 7.4 months.Conclusion. Pemetrexed at this dose and schedule showed moderate activity against advanced or recurrent cervical cancer that has failed prior chemotherapy. Data from other tumor sites has suggested synergy between pemetrexed and cisplatin and should be considered for further study.