title: A phase II study of gemcitabine in combination with oxaliplatin as first-line chemotherapy in patients with inoperable biliary tract cancer.
abstract: OBJECTIVE
  The aim of this study is to investigate the efficacy and safety of gemcitabine and oxaliplatin combination chemotherapy as first-line therapy in patients with inoperable biliary tract cancer (BTC).
  
  
  METHODS
  The treatment of this non-randomized phase II study consisted of gemcitabine 1,000 mg/m(2) intravenously (i.v.) on day 1 and oxaliplatin 85 mg/m(2) i.v. on day 2 every 2 weeks until disease progression, unaccep toxicity or patients' refusal.
  
  
  RESULTS
  From Sept 2006 to Oct 2007, 40 patients were enrolled. In the ITT analysis, the objective response rate was 15.0% and the disease control rate was 52.5%. The median overall survival (95% CI) was 8.5 months (6.4-10.7) and the time to progression was 4.2 months (0.5-7.9). For the 305 cycles, observed grade 3/4 toxicity was uncommon.
  
  
  CONCLUSIONS
  Gemcitabine and dose adjusted oxaliplatin combination chemotherapy had moderate anti-tumor activity and was well tolerated as a first-line treatment for patients with inoperable BTC.
authors.affiliation: Division of Hematology and Oncology, Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon Hospital, 1174, Jung-Dong, Wonmi-Gu, Bucheon-Si, Gyeonggi-Do, 420-853, South Korea.
authors.forename: Hyun Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Nam Su
authors.initials: NS
authors.lastname: Lee
authors.forename: Sang-Cheol
authors.initials: SC
authors.lastname: Lee
authors.forename: Sang Byung
authors.initials: SB
authors.lastname: Bae
authors.forename: Chan Kyu
authors.initials: CK
authors.lastname: Kim
authors.forename: Young Gook
authors.initials: YG
authors.lastname: Cheon
authors.forename: Young Seok
authors.initials: YS
authors.lastname: Kim
authors.forename: Jong Ho
authors.initials: JH
authors.lastname: Moon
authors.forename: Young Deok
authors.initials: YD
authors.lastname: Cho
authors.forename: Sang Heum
authors.initials: SH
authors.lastname: Park
authors.forename: Kyu Taek
authors.initials: KT
authors.lastname: Lee
authors.forename: Sung Kyu
authors.initials: SK
authors.lastname: Park
authors.forename: Jong-Ho
authors.initials: JH
authors.lastname: Won
authors.forename: Hee Sook
authors.initials: HS
authors.lastname: Park
authors.forename: Dae Sik
authors.initials: DS
authors.lastname: Hong
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D001859:Bone Neoplasms / Q000188:drug therapy* / Q000556:secondary; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy* / Q000556:secondary; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009944:Organoplatinum Compounds / Q000008:administration & dosage; D000077150:Oxaliplatin; D010534:Peritoneal Neoplasms / Q000188:drug therapy* / Q000556:secondary; D011379:Prognosis; D011446:Prospective Studies; D015996:Survival Rate; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D000093542:Gemcitabine