1. Phase II study of carboplatin and pemetrexed for the treatment of platinum-sensitive recurrent ovarian cancer.
- Author
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Matulonis UA, Horowitz NS, Campos SM, Lee H, Lee J, Krasner CN, Berlin S, Roche MR, Duska LR, Pereira L, Kendall D, and Penson RT
- Subjects
- Adult, Aged, Antineoplastic Combined Chemotherapy Protocols adverse effects, Boston, Carboplatin administration & dosage, Disease-Free Survival, Drug Administration Schedule, Fallopian Tube Neoplasms mortality, Fallopian Tube Neoplasms pathology, Female, Glutamates administration & dosage, Guanine administration & dosage, Guanine analogs & derivatives, Humans, Infusions, Intravenous, Kaplan-Meier Estimate, Middle Aged, Ovarian Neoplasms mortality, Ovarian Neoplasms pathology, Pemetrexed, Peritoneal Neoplasms mortality, Peritoneal Neoplasms pathology, Time Factors, Treatment Outcome, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Fallopian Tube Neoplasms drug therapy, Neoplasm Recurrence, Local, Ovarian Neoplasms drug therapy, Peritoneal Neoplasms drug therapy
- Abstract
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/m(2) 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
- 2008
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