Gemcitabine Plus High-Dose 5-Fu/Leucovorin in the Treatment of Advanced or Metastatic Carcinoma of the Biliary Tract

Inclusion criteria:

1. Histologically proven carcinoma of the biliary tract, including gallbladder carcinoma and cholangiocarcinoma. The disease should be either locally advanced to the extent that curative surgery is impossible or with documented distant metastasis.
2. Bi-dimensionally measurable disease by physical examination or image study (roentgenogram or computed tomography (CT) scan).
3. Age > 18 years. For patients older than 70 years of age, detailed evaluation of the organ function reserves must be done before enrollment unto protocol treatment.
4. Karnofsky performance status> 60%
5. Adequate bone marrow reserves, defined as white blood cell (WBC)>4,000/ml, absolute neutrophil count (ANC)> 1,500/ml, platelet> 150,000/ml.
6. Liver transaminases <5 times upper normal limits; total bilirubin <3 mg/dl; serum creatinine < 1.5 mg/dl
7. Serum triglyceride level >70 mg/dl
8. No prior cytotoxic chemotherapy. Previous radiotherapy is allowed if the treatment was completed at least 6 weeks before the enrollment onto this study.
9. Patients of childbearing age should have effective contraception during the study period.
10. All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional guidelines.

Exclusion criteria:

1. Patients who are receiving concurrent radiotherapy, chemotherapy or other experimental therapy.
2. Patients who refuse port-A catheter implantation
3. Patients with brain or leptomeningeal metastases.
4. Patients who have significant cardiac arrhythmia or acute myocardial infarction within 6 months before entry.
5. Patients who have major systemic diseases that the attending physicians considered inappropriate for systemic chemotherapy.
6. Life expectancy less than 2 months.
7. Pregnant or nursing women may not participate. Women or men with reproductive potential may not participate unless they have agreed to use an effective contraceptive method.
8. Patients who have previous malignancy except for the following: adequately treated basal cell or squamous cell skin cancers, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any cancer from which the patient has been disease-free for 5 years.