Gemcitabine, 5-fluorouracil, and leucovorin in advanced biliary tract and gallbladder carcinoma: A north central cancer treatment group phase II trial

Steven R. Alberts, Hani Al-Khatib, Michelle R. Mahoney, Lawerence Burgart, Peter J. Cera, Patrick J. Flynn, Tom R. Finch, Ralph Levitt, Harold E. Windschitl, James A. Knost, Loren K. Tschetter, Muhammad Salim, Philip J. Stella, Ferdinand Addo, Martin Wiesenfeld, Daniel J. Walsh, John C. Michalak, James A. Mailliard

Research output: Contribution to journalArticlepeer-review

112 Scopus citations


BACKGROUND. Gemcitabine has broad activity in a variety of solid tumors including biliary tract carcinomas. The authors evaluated 6-month survival, response, and toxicity associated with a combination of gemcitabine, 5-fluorouracil (5-FU), and leucovorin (LV) in patients with unresectable or metastatic biliary tract of gallbladder adenocarcinoma (ACA). METHODS. A 4-week course included 1000 mg/m2 gemcitabine by intravenous infusion over 30 minutes on Days 1, 8, and 15, 25 mg/m2 LV by intravenous push, and 600 mg/m2 5-FU by intravenous push after LV. RESULTS. Forty-two patients were enrolled in 6 months, 35 of whom had metastatic disease. Patients with biliary tract ACA included 24 with hepatic disease (19 patients had intrahepatic disease and 5 patients had extrahepatic disease) and 4 with disease in the ampulla of Vater. All patients were evaluable and received a median of 4 courses of treatment (range, 1-21 courses). Commonly occurring severe toxicity (NCI CTC Grade 3 or worse) included: dyspnea (four patients), nausea (four patients), fatigue (seven patients), thrombocytopenia (six patients), emesis (four patients), and diarrhea (four patients). Five partial responses (9.5%) occurred, 3 of which were sustained for ≥ 8 weeks. No treatment-related deaths occurred. Thirty-two patients had disease progression and 38 died after a median follow-up of 20 months (range, 1.4-24 months). The median time to disease progression was 4.6 months (95% confidence interval [95% CI), 2.4-6.6%). The median survival period was 9.7 months (95% CI, 7-12%). CONCLUSIONS. This combination regimen was manageable in patients with advanced biliary tract and gallbladder ACA. Of 42 patients, 24 (57%) survived ≥ 6 months, satisfying the primary end point of the trial. The length of survival suggested that gemcitabine, 5-FU, and LV had benefit equivalent to gemcitabine alone.

Original languageEnglish (US)
Pages (from-to)111-118
Number of pages8
Issue number1
StatePublished - Jan 1 2005


  • 5-fluorouracil
  • Cholangiocarcinoma
  • Gallbladder adenocarcinoma
  • Gemcitabine
  • Leucovorin

ASJC Scopus subject areas

  • Oncology
  • Cancer Research


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