A phase II evaluation of pemetrexed (LY231514, IND #40061) in the treatment of recurrent or persistent platinum-resistant ovarian or primary peritoneal carcinoma: A study of the gynecologic oncology group

Abstract

5524 Objective: To estimate the anti-tumor activity of pemetrexed (LY231514) in patients with persistent or recurrent platinum-resistant epithelial ovarian or primary peritoneal cancer who have failed on higher priority treatment protocols and to determine the nature and degree of toxicity of pemetrexed in this cohort of patients. Methods: A multicenter cooperative group Phase II Trial was conducted by the Gynecologic Oncology Group (GOG). Patients must have had recurrent or persistent epithelial ovarian or primary peritoneal cancer 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. Response was assessed by RECIST criteria. Dose adjustment was permitted for toxicity. Treatment was continued until disease progression or unacceptable adverse effects. Results: From July 6, 2004 to August 23, 2006, 51 patients were entered by 15 member institutions of the GOG. Two patients were ineligible (wrong primary, low creatinine clearance) and one did not receive treatment. A total of 259 cycles (median: 4; range 1 to 19) of pemetrexed were administered with 40% of patients receiving 6 or more cycles. Overall, the treatment was well tolerated. More serious toxicities (grade 3 and 4) included neutropenia in 42%, leukopenia in 25%, anemia in 15%, and constitutional in 15%. No treatment-related deaths were reported. One patient (2%) had a complete and nine patients (19%) had partial responses with a median duration response of 6.8 months. Seventeen patients (35%) had stable disease for a median of 4.1 months. Eighteen patients (38%) had increasing disease. Three patients (6%) were inevaluable. Median progression-free survival (PFS) was 3.0+ months and overall survival (OS) was 11.4+ months. Conclusion: Pemetrexed has demonstrated activity in the treatment of recurrent platinum resistant ovarian carcinoma at the dose and schedule tested. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Expert Testimony Other Remuneration Lilly Oncology Lilly Oncology