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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
Gynecologic Oncology, 07/03/08
Miller DS et al. - In a trial to estimate the anti-tumor activity of pemetrexed in pts with advanced or recurrent carcinoma of the cervix that failed on higher priority treatment protocols and to determine the nature and degree of toxicity, it was found that pemetrexed at this dose and schedule showed moderate activity against advanced or recurrent cervical cancer that has failed prior chemotherapy
Methods- Pts must have had advanced or recurrent measurable carcinoma of the cervix, and failed 1 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
- 29 pts were entered by 10 member institutions of the GOG
- 2 pts did not receive treatment and thus were inevaluable
- 128 cycles were administered with 37% of pts receiving 6 or more cycles
- 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
- 4 pts had partial responses with a median response duration of 4.4 months
- Response rate for non-radiated or radiated disease sites was 25% and 7%, respectively
- 16 pts had stable disease and 7 pts had increasing disease
- Median progression-free survival was 3.1 months and overall survival was 7.4 months
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