title: Phase II study of carboplatin and pemetrexed for the treatment of platinum-sensitive recurrent ovarian cancer.
abstract: OBJECTIVE
  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.
  
  
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Medical Oncology, Dana-Farber Cancer Institute, Massachusetts General Hospital, Boston MA 02115, USA. Ursula_matulonis@dfci.harvard.edu
authors.forename: Ursula A
authors.initials: UA
authors.lastname: Matulonis
authors.forename: Neil S
authors.initials: NS
authors.lastname: Horowitz
authors.forename: Susana M
authors.initials: SM
authors.lastname: Campos
authors.forename: Hang
authors.initials: H
authors.lastname: Lee
authors.forename: Julie
authors.initials: J
authors.lastname: Lee
authors.forename: Carolyn N
authors.initials: CN
authors.lastname: Krasner
authors.forename: Suzanne
authors.initials: S
authors.lastname: Berlin
authors.forename: Maria R
authors.initials: MR
authors.lastname: Roche
authors.forename: Linda R
authors.initials: LR
authors.lastname: Duska
authors.forename: Lauren
authors.initials: L
authors.lastname: Pereira
authors.forename: Deborah
authors.initials: D
authors.lastname: Kendall
authors.forename: Richard T
authors.initials: RT
authors.lastname: Penson
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001900:Boston; D016190:Carboplatin / Q000008:administration & dosage; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D005971:Glutamates / Q000008:administration & dosage; D006147:Guanine / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D010051:Ovarian Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000068437:Pemetrexed; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D005971:Glutamates; D000068437:Pemetrexed; D006147:Guanine; D016190:Carboplatin