title: Combining gemcitabine and capecitabine in patients with advanced biliary cancer: a phase II trial.
abstract: OBJECTIVE
  Biliary cancer has a poor prognosis, and chemotherapy has had little impact. The objectives of this trial were to determine the response rate, time to disease progression, survival, and safety profile of the combination of gemcitabine and capecitabine (GemCap) in patients with advanced biliary cancer.
  
  
  METHODS
  Eligible patients had pathologically proven, locally advanced or metastatic adenocarcinoma arising from the intra- and extrahepatic bile ducts or gallbladder with no prior chemotherapy. Patients were treated on a 3-week cycle consisting of capecitabine at 650 mg/m(2) orally twice a day for 14 days and gemcitabine at a fixed dose of 1,000 mg/m(2) intravenously over 30 minutes on days 1 and 8.
  
  
  RESULTS
  Forty-five patients were enrolled between July 2001 and January 2004. Fifty-three percent of patients had cholangiocarcinoma, 47% had gallbladder cancer, and 89% had metastatic disease. The overall objective response rate was 31%, with an additional 42% of patients with stable disease, for a disease control rate of 73%. The median overall survival time was 14 months (95% CI, 7.3 months to not available), and the median progression-free survival time was 7 months (95% CI, 4.6 to 11.8 months). This chemotherapy combination was generally well tolerated. Transient neutropenia, thrombocytopenia, fatigue, and hand-foot syndrome were commonly observed but were easily managed without discontinuing further treatment.
  
  
  CONCLUSIONS
  The significant antitumor activity combined with a mild toxicity profile seen in this study argue that GemCap chemotherapy may benefit patients with advanced biliary cancer. This regimen warrants further evaluation in a randomized study with survival and quality of life end points.
authors.affiliation: Princess Margaret Hospital, 5-218, 610 University Ave, Toronto, Ontario, Canada. jennifer.knox@uhn.on.ca
authors.forename: Jennifer J
authors.initials: JJ
authors.lastname: Knox
authors.forename: David
authors.initials: D
authors.lastname: Hedley
authors.forename: Amit
authors.initials: A
authors.lastname: Oza
authors.forename: Ron
authors.initials: R
authors.lastname: Feld
authors.forename: Lillian L
authors.initials: LL
authors.lastname: Siu
authors.forename: Eric
authors.initials: E
authors.lastname: Chen
authors.forename: Mahsan
authors.initials: M
authors.lastname: Nematollahi
authors.forename: Gregory R
authors.initials: GR
authors.lastname: Pond
authors.forename: Jessica
authors.initials: J
authors.lastname: Zhang
authors.forename: Malcolm J
authors.initials: MJ
authors.lastname: Moore
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy* / Q000473:pathology; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D000069287:Capecitabine; D001651:Cholestasis, Extrahepatic / Q000188:drug therapy* / Q000473:pathology; D002780:Cholestasis, Intrahepatic / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D005706:Gallbladder Neoplasms / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D008875:Middle Aged; D011379:Prognosis; D016019:Survival Analysis; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D005472:Fluorouracil; D000093542:Gemcitabine