Irinotecan and Capecitabine as Second-line Treatment for Advanced/Metastatic Biliary Tract Cancers

Inclusion Criteria: * Must be 18 years of age or older * Histological proven un-resectable or metastatic biliary tract cancer (gallbladder cancer included) with radiologic progression after initial gemcitabine plus platinum (cisplatin, carboplatin or oxaliplatin) regimen * Computerized tomography (CT) or magnetic resonance imaging (MRI) with measurable lesions no more than 28 days prior to enrollment. Lesions should be at least 1.5 cm in longest dimension. * Patients with evaluable only disease, effusion, needs to have cytology proven malignant cells present in the effusion. * Patients who cannot tolerate or developed allergic reaction to either gemcitabine or platinum compounds, even without radiographic progression will be eligible. * Patients must have a life expectancy of at least 12 weeks * Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 - 2. * Patients must be able to understand and sign informed consent. * Patients should have adequate bone marrow function defined by an absolute peripheral granulocyte count of ≥ 1,500 cells/mm3 and platelet count ≥ 60,000/mm3 and absence of a regular red blood cell transfusion requirement. * Patients should have adequate hepatic function with a total bilirubin ≤ 4.0 mg/dl, could be ≤ 10 mg/dl if a functional biliary drain is placed within three days of enrollment and documented declining total bilirubin level, and adequate renal function as defined by a serum creatinine ≤ 1.5 X upper limit of normal. * Patients with concurrent basal cell carcinoma and/or squamous cell carcinoma of skin are eligible. * Patients with other malignancies require having at least 5 year disease-free interval before enrollment * Patients who were treated with either irinotecan and/or capecitabine for cancers other than biliary tract cancer are eligible as long as treatment-free interval is greater than 3 years. Exclusion Criteria: * Patients with symptomatic central nervous system (CNS) metastases are excluded. Need to demonstrate stable CNS metastases for at least 3 months * Pregnant women and nursing mothers are not eligible. * Patients of child bearing potential must agree to use adequate contraception * No heart attack within 6 months of enrollment * No stroke (embolic and hemorrhage) within 6 months of enrollment. * No New York Heart Association Class III/IV congestive heart failure (CHF). * Severe chronic obstructive pulmonary disease (COPD) requires ≥ 2 L (Liters) /minute of oxygen. * Known history of allergic reaction to irinotecan and/or capecitabine. * Known history of 5-fluorouracil (5-FU) or capecitabine induced cardiac toxicity.