Phase I Study of Combination of Capecitabine and Erlotinib Concurrent With Radiotherapy in Patients With Non-Operable Locally 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.