Originally published as JCO Early Release 10.1200/JCO.2008.17.0282 on November 10 2008

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Phase II Study of Carboplatin and Pemetrexed for the Treatment of Platinum-Sensitive Recurrent Ovarian Cancer

Ursula A. Matulonis, Neil S. Horowitz, Susana M. Campos, Hang Lee, Julie Lee, Carolyn N. Krasner, Suzanne Berlin, Maria R. Roche, Linda R. Duska, Lauren Pereira, Deborah Kendall, Richard T. Penson

From the Department of Medical Oncology, Dana-Farber Cancer Institute; Division of Gynecologic Oncology, Brigham and Women's Hospital; and Biostatistics Center and Department of Hematology and Oncology, Massachusetts General Hospital, Boston MA

Corresponding author: Ursula A. Matulonis, MD, Dana-Farber Cancer Institute, 44 Binney St, Boston, MA 02115; e-mail: Ursula_matulonis{at}dfci.harvard.edu

Purpose More efficacious, less toxic combinations are needed to treat platinum-sensitive recurrent epithelial ovarian cancer (EOC). Pemetrexed is a multitargeted antifolate with manageable toxicity and has been combined with carboplatin to treat other cancers.

Patients and Methods This is a phase II study of carboplatin area under the curve 5 with pemetrexed 500 mg/m² administered intravenously on day 1 every 21 days for six cycles or for up to eight cycles if clinical benefit occurred. Eligible patients had platinum-sensitive recurrent EOC, peritoneal serous cancer, or fallopian tube cancer. The primary objective was to determine response rate defined by Response Evaluation Criteria in Solid Tumors; other end points included toxicities, progression-free survival (PFS), and overall survival (OS).

Results Forty-five patients were accrued; 44 patients received treatment. Overall response rate was 51.1%; there were no complete responses (0%), 23 confirmed partial responses (51.1%), two unconfirmed partial responses (4.4%), 14 patients with stable disease (31.1%), and two patients with progressive disease after two cycles (4.4%). Grade 3 and 4 hematologic toxicities included neutropenia (41%), thrombocytopenia (23%), and anemia (9%); there were no episodes of febrile neutropenia. Grade 3 and 4 nonhematologic toxicities included fatigue (11%), nausea (5%), vomiting (5%), diarrhea (5%), syncope (5%), and pulmonary embolism (5%). Median PFS time was 7.57 months (95% CI, 6.44 to 10.18 months), mean OS time was 20.3 months, and median OS has not yet been reached with a mean follow-up time of 15.3 months.

Conclusion Carboplatin/pemetrexed is a well-tolerated regimen with activity in platinum-sensitive recurrent EOC; further testing of this regimen in platinum-sensitive EOC patients is warranted.

published online ahead of print at www.jco.org on November 10, 2008.

Supported by Eli Lilly & Co, Indianapolis, IN.

Presented in part at the 15th International Meeting of the European Society of Gynaecological Oncology, October 28-November 1, 2007, Berlin Germany; and the 39th Annual Meeting on Women's Cancer, Society of Gynecologic Oncology, March 9-12, 2008, Tampa, FL.

Authors’ disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical trial information can be found for the following: NCT00230542 [ClinicalTrials.gov] .

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