A Phase II Trial of Gemcitabine and Cisplatin In Unresectable Or Metastatic Biliary Tract and Gallbladder Cancer

Inclusion Criteria:

- Histologically-confirmed, locally unresectable or metastatic biliary tract (bile
ducts, hepatic duct, cystic duct, common bile duct, ampulla of Vater) or gallbladder
adenocarcinoma. Patients must have at least one measurable lesion greater than 1 cm,
by Response Evaluation Criteria in Solid Tumors (RECIST) criteria outside of prior
radiation field.

- Zero to one prior chemotherapy for biliary tract or gallbladder cancer. Prior
chemoembolization to the liver allowed as long as measurable disease is outside of
chemoembolization area and other baseline characteristics are met. No prior
gemcitabine or cisplatin therapy allowed.

- No chemotherapy within past 3 weeks of initiation of therapy (6 weeks if prior
therapy was mitomycin C or nitrosurea)

- Chronological age > 18 years.

- ECOG performance status 0-2; life expectancy >12 weeks.

- Laboratory values: ANC greater than or equal to 1500/mm3; platelets greater than or
equal to 100,000/mm3; SGOT and SGPT less than or equal to 3x upper limits of normal
(unless liver is involved with tumor, in which case the transaminases must be less
than or equal to 5 x upper limits of normal); total bilirubin less than or equal to
2.0 mg/dL.

- Creatinine less than or equal to 1.8 mg/dL or creatinine clearance greater than or
equal to 50 mL/min

- All patients must sign informed consent.

- Patients may have prior placement of stents or shunts to relieve obstruction.

Exclusion Criteria:

- Patients with either clinically apparent central nervous system metastases or
carcinomatous meningitis.

- Myocardial infarction in the past six months.

- Major surgery in the past two weeks.

- Uncontrolled serious medical or psychiatric illness.

- Women must not be pregnant or lactating. Both men and women of childbearing
potential must be advised of the importance of using effective birth control measures
during the course of the study.

- Patients with concurrent malignancy of any site, except for limited basal cell
carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix;
patients with any other malignancy within 5 years of study entry, except for
curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or
carcinoma in situ of the cervix.