title: A phase II trial of capecitabine in heavily pre-treated platinum-resistant ovarian cancer.
abstract: OBJECTIVE
  To determine the activity of capecitabine in women with platinum-resistant ovarian cancer.
  
  
  METHODS
  In this multi-centre phase II trial, 35 patients with platinum-resistant ovarian, primary peritoneal or fallopian tube carcinomas were treated with capecitabine 1250 mg/m(2) twice daily for 14 days every 21 days. Platinum resistance was defined as progression within 4 months of completing the last platinum and all patients had previously received a taxane. Response was assessed by both RECIST criteria for patients with measurable disease and CA125 criteria. Responders were defined as patients with measurable disease who achieved a CR or PR according to RECIST criteria, patients without measurable disease who met the CA125 criteria for response and patients with stable measurable disease who met the CA125 criteria for response.
  
  
  RESULTS
  Patients had received a median of four prior chemotherapy regimens (range 1-9). The median number of cycles of capecitabine administered was 3 (range 1-10). The response rate using the combined RECIST and CA125 criteria was 9% (95% CI 2-25%). In patients evaluable using RECIST criteria, the response rate was 5% (95% CI 0-25%). In patients evaluable for CA125 response, the response rate was 7% (95% CI 1-22%). The median progression-free survival was 2.3 months, and the median survival was 7.1 months. Treatment was generally well tolerated with most frequent grade 3 toxicities being hand-foot syndrome (17%) and diarrhea (9%).
  
  
  CONCLUSIONS
  Capecitabine is well tolerated but has limited activity in patients with heavily pre-treated platinum-resistant ovarian cancer.
authors.affiliation: Department of Medical Oncology, Prince of Wales Hospital, Sydney, Australia. Danny.Rischin@petermac.org
authors.forename: Danny
authors.initials: D
authors.lastname: Rischin
authors.forename: Kelly-Anne
authors.initials: KA
authors.lastname: Phillips
authors.forename: Michael
authors.initials: M
authors.lastname: Friedlander
authors.forename: Paul
authors.initials: P
authors.lastname: Harnett
authors.forename: Michael
authors.initials: M
authors.lastname: Quinn
authors.forename: Gary
authors.initials: G
authors.lastname: Richardson
authors.forename: Andrew
authors.initials: A
authors.lastname: Martin
mesh_terms: D000328:Adult; D000368:Aged; D000964:Antimetabolites, Antineoplastic / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use*; D019008:Drug Resistance, Neoplasm; D005185:Fallopian Tube Neoplasms / Q000188:drug therapy; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009944:Organoplatinum Compounds / Q000627:therapeutic use; D010051:Ovarian Neoplasms / Q000188:drug therapy*; D010534:Peritoneal Neoplasms / Q000188:drug therapy
chemical_list: D000964:Antimetabolites, Antineoplastic; D009944:Organoplatinum Compounds; D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil