title: Phase II trial of weekly 24-hour infusion of gemcitabine in patients with advanced gallbladder and biliary tract carcinoma.
abstract: BACKGROUND
  Patients with advanced gallbladder and biliary tract carcinoma face a dismal prognosis, as no effective palliative chemotherapy exists. The antitumor effect of gemcitabine is schedule-dependent rather than dose-dependent. We evaluated the activity of a prolonged infusion of gemcitabine in advanced gallbladder and biliary tract carcinomas.
  
  
  METHODS
  Nineteen consecutive eligible patients were enrolled. All patients were required to have histologically confirmed diagnosis and measurable disease. Gemcitabine was infused over 24 hours at a dose of 100 mg/m2 on days 1, 8, and 15. Treatment was repeated every 28 days until progression of disease or limiting toxicity. Tumor response was evaluated every second course by computed tomography (CT) scans.
  
  
  RESULTS
  Eighteen patients were evaluable for response. A total of 89 cycles of therapy were administered. One partial response was observed (6%; 95% confidence interval (CI): 0-27%) and ten additional patients had stable disease for at least two months (disease control rate 61%; 95% CI: 36-83%). The therapy was well tolerated, with moderate myelosuppression as the main toxicity. The median time to tumor progression and median overall survival was 3.6 months (95% CI 2.6-4.6 months) and 7.5 months (95% CI 6.5-8.5 months), respectively.
  
  
  CONCLUSIONS
  Weekly 24-hour gemcitabine at a dose of 100 mg/m2 is well tolerated. There was a relatively high rate of disease control for a median duration of 5.3 months (range 2.8-18.8 months). However, the objective response rate of this regimen in gallbladder and biliary tract carcinomas was limited.
authors.affiliation: Department of Internal Medicine II, Technical University of Munich, Klinikum rechts der Isar, Ismaninger Str, 22, 81675 München, Germany. stefan_ruckert@yahoo.de
authors.forename: Stefan
authors.initials: S
authors.lastname: von Delius
authors.forename: Christian
authors.initials: C
authors.lastname: Lersch
authors.forename: Ewert
authors.initials: E
authors.lastname: Schulte-Frohlinde
authors.forename: Martina
authors.initials: M
authors.lastname: Mayr
authors.forename: Roland M
authors.initials: RM
authors.lastname: Schmid
authors.forename: Florian
authors.initials: F
authors.lastname: Eckel
mesh_terms: D000230:Adenocarcinoma / Q000378:metabolism; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000964:Antimetabolites, Antineoplastic / Q000008:administration & dosage / Q000627:therapeutic use*; D001661:Biliary Tract Neoplasms / Q000188:drug therapy*; D002277:Carcinoma / Q000188:drug therapy*; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D018450:Disease Progression; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D005706:Gallbladder Neoplasms / Q000188:drug therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D015233:Models, Statistical; D013997:Time Factors; D014057:Tomography, X-Ray Computed; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D000964:Antimetabolites, Antineoplastic; D003841:Deoxycytidine; D000093542:Gemcitabine