Phase II trial of mitomycin C (MMC) in advanced gallbladder and biliary tree carcinoma. An EORTC Gastrointestinal Tract Cancer Cooperative Group Study.
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.
Taal
B G
BG
Netherlands Cancer Institute, Amsterdam.
Audisio
R A
RA
Bleiberg
H
H
Blijham
G H
GH
Neijt
J P
JP
Veenhof
C H
CH
Duez
N
N
Sahmoud
T
T
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
D016685:Mitomycin