title: A phase II trial of 5-fluorouracil, leucovorin, and carboplatin in patients with unresectable biliary tree carcinoma.
abstract: BACKGROUND
  Unresectable adenocarcinoma of the biliary tree are associated with a very poor prognosis. 5-fluorouracil (5-FU) combination regimens have produced objective response rates in approximately 10-20% of patients. Leucovorin increases the selective cytotoxicity of 5-FU. There also are encouraging reports of carboplatin in combination with 5-FU in other gastrointestinal tract malignancies.
  
  
  METHODS
  Fourteen consecutive eligible patients were treated with a combination of carboplatin, 300 mg/m2, intravenously (i.v.) on Day 1 only and 5-FU, 400 mg/m2, i.v. with leucovorin, 25 mg/m2, i.v. on Days 1-4. All patients were required to have a histologically confirmed diagnosis and measurable disease. Patients were evaluated for response, survival, and toxicity.
  
  
  RESULTS
  A total of 48 cycles of therapy were delivered. The median survival was 5 months. One patient achieved complete remission and two others partial remission, for a total response rate of 21.4%. Four additional patients had stable disease for a median duration of 4 months. The therapy was well tolerated, with moderate myelosuppression as the main dose-limiting toxicity.
  
  
  CONCLUSIONS
  The current combination regimen of leucovorin-modulated 5-FU with carboplatin is well tolerated with appropriate supportive care, produces significant objective responses in 21% of patients with biliary tree carcinoma, and should be considered for the treatment of this disease.
authors.affiliation: Division of Hematology/Oncology, Boston Center for Liver Cancer, Harvard Medical School, Massachusetts, USA.
authors.forename: P M
authors.initials: PM
authors.lastname: Sanz-Altamira
authors.forename: K
authors.initials: K
authors.lastname: Ferrante
authors.forename: R L
authors.initials: RL
authors.lastname: Jenkins
authors.forename: W D
authors.initials: WD
authors.lastname: Lewis
authors.forename: M S
authors.initials: MS
authors.lastname: Huberman
authors.forename: K E
authors.initials: KE
authors.lastname: Stuart
mesh_terms: D000230:Adenocarcinoma / Q000188:drug therapy*; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001650:Bile Duct Neoplasms / Q000188:drug therapy*; D016190:Carboplatin / Q000008:administration & dosage; D018281:Cholangiocarcinoma / Q000188:drug therapy*; D004347:Drug Interactions; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D006801:Humans; D002955:Leucovorin / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000188:drug therapy*
chemical_list: D016190:Carboplatin; D002955:Leucovorin; D005472:Fluorouracil