Gemcitabine and Capecitabine to Treat Patients With Advanced Pancreatic and Biliary Cancers

Inclusion Criteria

• •Histologically-confirmed pancreatic adenocarcinoma or biliary tract carcinoma (cholangiocarcinoma or gallbladder cancer)
• •Disease must not be amenable to surgical resection. Patients with either locally advanced or metastatic disease are eligible
• •No prior systemic therapy for their diagnosis
• •ECOG performance score of 0-1
• •Evidence of either or both of the following:
• •1. RECIST-defined measurable disease (lesions that can be accurately measured in at least one dimension with the longest diameter ≥ 20mm using conventional techniques or ≥10 mm with spiral CT scan)
• •2. An elevated serum CA19-9 at baseline ( ≥ 2X ULN)
• •Female patients must be either surgically sterile or postmenopausal, or if of childbearing potential must have a negative pregnancy test (serum or urine) prior to enrollment and agree to use effective barrier contraception during the period of therapy. Oral, implantable, or injectable contraceptives may be affected by cytochrome P450 interactions, and are therefore not considered effective for this study. Male patients must be surgically sterile or must agree to use effective contraception during the period of therapy. The definition of effective contraception will be based on the judgment of the investigator.
• •Adequate bone marrow function:
• •1. ANC ≥ 1500/uL
• •2. platelet count ≥ 100,000/uL
• •3. hemoglobin ≥ 9.0 g/dL
• •Adequate hepatic function:
• •1. Total bilirubin ≤ 1.5 X ULN
• •2. AST (SGOT) ≤ 2.5 X ULN
• •3. ALT (SGPT) ≤ 2.5 X ULN
• •Adequate renal function as determined by either:
• •1. Calculated or measured creatinine clearance ≥ 40 mL/min (for calculated creatinine clearance, Cockroft-Gault equation will be used)
• •2. Serum creatinine ≤ 1.5 X ULN
• •Ability to swallow oral medications
• •Ability to understand the nature of this study protocol and give written informed consent
• •Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.