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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 or gallbladder adenocarcinoma (ACA).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.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%).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. Cancer 2005. © 2004 American Cancer Society.