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