Efficacy Study of Gemcitabine, Paclitaxel, and Irradiation in the Treatment of Pancreatic Cancer

Inclusion Criteria: Pathologically confirmed adenocarcinoma of the pancreas. Patients must have locally advanced/unresectable disease based on institutional standardized criteria of unresectability. Patients with residual disease after resection (R-1 or -2, micro and macroscopic residual) are eligible. Patients with biliary or gastroduodenal obstruction must have drainage prior to starting chemoradiation. All malignant disease must be encompassed within a single irradiation field (12 x 12 cm maximum). All patients must have radiographically assessable disease. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic resonance imaging (MRI) scan must be obtained within four weeks of study entry. Eastern Cooperative Oncology Group (ECOG) performance status 0-1. Required entry laboratory parameters: granulocytes >/= 1,800/µl, platelet count >/= 100,000/µl, bilirubin < 2.0 mg/dL, alanine aminotransferase (ALT) < 3 x upper limit of normal, and creatinine < 3.0 mg/dL. Signed study-specific consent form prior to study entry. Exclusion Criteria: Patients who have evidence of metastatic disease in the major viscera and/or peritoneal seeding or ascites. Previous irradiation to the planned field; or previous chemotherapy for pancreatic cancer (Gemzar® or Taxol®). Malignancy (within the past two years) except for non-melanomatous skin cancer or carcinoma in situ of the cervix, uterus, or bladder. Patients who have significant infection or other coexistent medical condition that would preclude protocol therapy.