title: Phase II trial of mitomycin C (MMC) in advanced gallbladder and biliary tree carcinoma. An EORTC Gastrointestinal Tract Cancer Cooperative Group Study.
abstract: BACKGROUND
  Based on a recent pharmacokinetic study suggesting that high biliary levels of mitomycin C (MMC) may be achieved as a result of an entero-hepatic recycling mechanism, we conducted a Phase II EORTC trial which involved MMC administration to patients with non-resectable biliary tract carcinoma.
  
  
  METHODS
  Of the 34 patients entered in the study, 30 were eligible (11m + 19f, median age 58 yrs). I.V. bolus injections of 15 mg/m2 MMC were administered at six-week intervals. The tumors were confined to the liver in 17 patients and 13 had extra-hepatic localizations.
  
  
  RESULTS
  All 30 eligible patients were evaluable for toxicity and response. Mild thrombocytopenia was the main toxic side effect. Severe, WHO grade III/IV thrombocytopenia was limited to 4 patients. The haemolytic uraemic syndrome was not observed and there were no toxic deaths. Of 30 patients, 3 had partial remissions (overall response 10%, 95% confidence interval 2%-27%).
  
  
  CONCLUSIONS
  This study, the largest such ongoing phase II trial, shows no significant activity of single-agent MMC in patients with advanced biliary tract carcinoma.
authors.affiliation: Netherlands Cancer Institute, Amsterdam.
authors.forename: B G
authors.initials: BG
authors.lastname: Taal
authors.forename: R A
authors.initials: RA
authors.lastname: Audisio
authors.forename: H
authors.initials: H
authors.lastname: Bleiberg
authors.forename: G H
authors.initials: GH
authors.lastname: Blijham
authors.forename: J P
authors.initials: JP
authors.lastname: Neijt
authors.forename: C H
authors.initials: CH
authors.lastname: Veenhof
authors.forename: N
authors.initials: N
authors.lastname: Duez
authors.forename: T
authors.initials: T
authors.lastname: Sahmoud
mesh_terms: D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D002277:Carcinoma / Q000188:drug therapy* / Q000556:secondary; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy; D006801:Humans; D008297:Male; D008875:Middle Aged; D016685:Mitomycin / Q000627:therapeutic use*; D016019:Survival Analysis
chemical_list: D016685:Mitomycin