A Phase II Study of Gemcitabine in Combination With Capecitabine in Advanced Cholangiocarcinoma

Study start date: October 1, 2002

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed cholangiocarcinoma or carcinoma of the gallbladder Advanced and/or inoperable disease Measurable disease At least 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR ≥ 10 mm by spiral CT scan No known brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Karnofsky 60-100% Life expectancy More than 2 months Hematopoietic WBC ≥ 3,000/mm^3 Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin < 3 mg/dL Renal Creatinine ≤ 1.6 mg/dL Cardiovascular No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No prior allergic reaction attributed to compounds of similar chemical or biological composition to study drugs No ongoing or active infection No psychiatric illness or social situation that would preclude study compliance No other concurrent uncontrolled illness PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy More than 4 weeks since prior chemotherapy and recovered No more than 1 prior chemoembolization OR chemoradiotherapy regimen for locally advanced biliary tract cancer No other prior chemotherapy (except adjuvant therapy) Endocrine therapy Not specified Radiotherapy See Chemotherapy More than 4 weeks since prior radiotherapy and recovered Surgery Not specified Other No other concurrent investigational agents No other concurrent anticancer agents or therapies