title: Phase II study of mFOLFOX3 (5-fluorouracil, leucovorin, oxaliplatin) as second-line treatment after gemcitabine failure in patients with unresectable/metastatic biliary tract cancer.
abstract: OBJECTIVE
  We conducted a phase II trial of 5-fluorouracil and oxaliplatin combination chemotherapy as a second-line treatment in unresectable/metastatic biliary tract cancer patients who had failed gemcitabine-based chemotherapy.
  
  
  METHODS
  Patients treated with gemcitabine-based palliative treatment were enrolled in this study. Patients were received modified FOLFOX3 (mFOLFOX3) consists of oxaliplatin 85 mg/m(2) (day 1) and leucovorin 30 mg (days 1, 2) followed by 5-fluorouracil 1,500 mg/m(2) (days 1, 2) every 2 weeks.
  
  
  RESULTS
  Between March 2010 and June 2012, a total of 30 patients were enrolled in this study. Twenty-eight patients were measurable for treatment response. One achieved complete response, and one a partial response was observed. Overall response rate was 7.1% (95% confidence interval 0.9-23.5%). The median progression-free survival was 1.6 months, and the median overall survival was 4.4 months. Grade 3-4 hematologic toxicities included neutropenia (6.7%) and thrombocytopenia (3.4%). The most common non-hematologic toxicity was neuropathy (22.2%). However, the most common grade 3-4 non-hematologic toxicity was hyperbilirubinemia (5.0%). There was one treatment-related death due to neutropenic infection.
  
  
  CONCLUSIONS
  mFOLFOX3 as a second-line regimen has modest effect and tolerable toxicity in unresectable/metastatic biliary tract cancer patients who have been treated previously via gemcitabine-based chemotherapy.
authors: Division of Hematology/Oncology, Department of Internal Medicine, Chung-Ang University Hospital, Chung-Ang University College of Medicine, 224 Heukseok-dong, Dongjak-gu, Seoul, 156-755, Korea.
authors: In Gyu
authors: IG
authors: Hwang
authors: Joung-Soon
authors: JS
authors: Jang
authors: Sung Yong
authors: SY
authors: Oh
authors: Myung Hwan
authors: MH
authors: Rho
authors: Suee
authors: S
authors: Lee
authors: Young Suk
authors: YS
authors: Park
authors: Joon Oh
authors: JO
authors: Park
authors: Eun Mi
authors: EM
authors: Nam
authors: Hyo Rak
authors: HR
authors: Lee
authors: Hyun Jung
authors: HJ
authors: Jun
authors: Kyong-Choun
authors: KC
authors: Chi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D053208:Kaplan-Meier Estimate; D002955:Leucovorin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D009944:Organoplatinum Compounds / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D000077150:Oxaliplatin; D011446:Prospective Studies; D017211:Treatment Failure; D000093542:Gemcitabine
chemical_list: D009944:Organoplatinum Compounds; D000077150:Oxaliplatin; D003841:Deoxycytidine; D002955:Leucovorin; D005472:Fluorouracil; D000093542:Gemcitabine