Tarceva and Capecitabine for Pancreatic Cancer

Inclusion Criteria: Metastatic pancreatic carcinoma (excluding pancreatic endocrine tumors) Only patients with measurable disease ECOG performance status < or equal to 1 Life expectancy >12 weeks Signed informed consent Failed or intolerance to first-line therapy for metastatic disease with a gemcitabine-containing regimen. Patients may have received adjuvant therapy in addition to one prior regimen for metastatic disease. >4 weeks must have elapsed from the completion of previous chemotherapy and patients must have recovered from any related toxicities >4 weeks must have elapsed from the participation in any investigational drug study Laboratory values: ANC > 1500/mm3; Hemoglobin > 9.0 gm/dl; Platelets > 100,000/mm3; SGOT <2.5 X upper limit of normal; or <5 X upper limit of normal if evidence of liver metastases; Alkaline phosphatase < 2.5 X upper limit of normal; or < 5 X upper limit of normal if evidence of liver metastases; Total bilirubin < 1.5 X upper limit of normal; Creatinine clearance > 50 cc/min (by Cockroft - Gault or as determined from a 24-hour urine collection). Exclusion Criteria: Prior therapy with capecitabine or epidermal growth factor receptor (EGFR) inhibitors More than one prior chemotherapy treatment regimen for metastatic disease Clinically apparent central nervous system (CNS) metastases or carcinomatous meningitis Clinically significant cardiac disease (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication or heart attack within the last 12 months). Major surgery within 4 weeks of the start of study treatment, without complete recovery. Evidence of CNS metastases (unless CNS metastases have been stable for > 3 months) or history of uncontrolled seizures, central nervous system disorders Uncontrolled serious medical or psychiatric illness Women must not be pregnant or lactating Concurrent radiation therapy Other active malignancy Inability to swallow tablets Patients lacking physical integrity of the upper gastrointestinal tract or who have malabsorption syndrome Prior unanticipated severe reaction to fluoropyrimidine therapy, or known sensitivity to 5-fluorouracil