title: A phase II trial of gemcitabine and capecitabine in patients with unresectable or metastatic gallbladder cancer or cholangiocarcinoma: Southwest Oncology Group study S0202.
abstract: OBJECTIVE
  Patients with gallbladder cancer or cholangiocarcinoma were treated with the combination of gemcitabine 1,000 mg/m(2) IV over 100 min on days 1 and 8 and capecitabine 650 mg/m(2) BID PO on days 1-14, administered every 21 days.
  
  
  METHODS
  The primary objective of this study was to assess the response rate (confirmed complete and partial responses) of gemcitabine and capecitabine used in advanced/metastatic biliary neoplasms. Secondary objectives included overall survival and toxicities.
  
  
  RESULTS
  The study accrued 57 patients from September 2003 to April 2005. Three patients were ineligible, and two others received no treatment. Characteristics of analyzable patients: 35 (67%) cholangiocarcinoma, 17 (33%) gallbladder cancer; PS 0 (18 pts), 1 (26 pts), 2 (8 pts); 26 (50%) men; median age 58.8 years (29.5-85.6). Among 51 patients evaluated for toxicity, 6 experienced grade 4 toxicities. Among 52 patients, there were 7 confirmed partial responses for a confirmed response probability of 13% (95% CI: 6-26%). Six patients had an unconfirmed partial response for an overall response probability of 25% (95% CI: 14-39%). Twelve patients (23%) demonstrated stable disease. The 6-month overall survival was 55% (95% CI: 41-69%), and median survival was 7 months (95% CI: 5-8 months).
  
  
  CONCLUSIONS
  The combination of gemcitabine and capecitabine is a well-tolerated regimen with activity in patients with advanced gallbladder cancer and cholangiocarcinoma.
authors.affiliation: Norris Comprehensive Cancer Center, University of Southern California, 1441 Eastlake Ave, Rm 3457, Los Angeles, CA 90033, USA. iqbal@usc.edu
authors.forename: Syma
authors.initials: S
authors.lastname: Iqbal
authors.forename: Cathryn
authors.initials: C
authors.lastname: Rankin
authors.forename: Heinz-Josef
authors.initials: HJ
authors.lastname: Lenz
authors.forename: Philip J
authors.initials: PJ
authors.lastname: Gold
authors.forename: Syed A
authors.initials: SA
authors.lastname: Ahmad
authors.forename: Anthony B
authors.initials: AB
authors.lastname: El-Khoueiry
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Messino
authors.forename: Randall F
authors.initials: RF
authors.lastname: Holcombe
authors.forename: Charles D
authors.initials: CD
authors.lastname: Blanke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001653:Bile Ducts, Intrahepatic; D000069287:Capecitabine; D018281:Cholangiocarcinoma / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005706:Gallbladder Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D013940:Thymidylate Synthase / Q000235:genetics; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D000069287:Capecitabine; D013940:Thymidylate Synthase; D005472:Fluorouracil; D000093542:Gemcitabine