Combination Study of Capecitabine and Erlotinib Concurrent With Radiotherapy for Non-Operable Advanced Pancreatic Cancer

Inclusion Criteria:

• Histologic or cytologic diagnosis of adenocarcinoma of the pancreas that is locally advanced & not amenable to resection with curative intent.
• Must not have received prior systemic therapy for locally advanced disease.
• ECOG performance status must be 0-2.
• Adequate hepatic, renal & bone marrow function.
• Radiographic evidence of disease is required.
• Life expectancy > 12 weeks.

Exclusion Criteria:

• Prior treatment with Capecitabine & other EGFR inhibitor.
• Patients with GI tract disease resulting in an inability to take oral medications.
• Significant GI disorders with diarrhea as a major symptom.
• Uncontrolled intercurrent illness including active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmias now well controlled with medication, myocardial infarction within the previous 6 months, psychiatric illness/social situations that would limit compliance with study requirements.
• Patients with metastases.
• Patients who have had chemotherapy.
• Patients may not be receiving any other investigational agents, or have participated in any investigational drug study.
• Extensive symptomatic fibrosis of the lungs.
• Females who are pregnant or lactating.
• History of any other malignancy in the last 2 years, except prior history of in situ cancer, basal or squamous cell skin cancer are eligible.
• Known DPD deficiency.
• Receiving therapeutic doses of Coumarin-derivative anticoagulant therapy. Patients requiring anticoagulation who may be safely switched to LMWH are eligible.