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

Based on our previous experience with the use of a weekly paclitaxel dose of 60 mg/m2 and
hyperfractionated radiation therapy 63.8 Gy, we are conducting this study incorporating the
use of Gemcitabine at a dose level of 75 mg/m2/week in addition to our prior protocol.

Inclusion Criteria:

1. Pathologically confirmed adenocarcinoma of the pancreas.

2. Patients must have locally advanced/unresectable disease based on institutional
standardized criteria of unresectability.

3. Patients with residual disease after resection (R-1 or -2, micro and macroscopic
residual) are eligible.

4. Patients with biliary or gastroduodenal obstruction must have drainage prior to
starting chemoradiation.

5. All malignant disease must be encompassed within a single irradiation field (12 x 12
cm maximum).

6. All patients must have radiographically assessable disease.

7. Electrocardiogram (EKG), chest x-ray, abdominal computed tomography (CT)/magnetic
resonance imaging (MRI) scan must be obtained within four weeks of study entry.

8. Eastern Cooperative Oncology Group (ECOG) performance status 0-1.

9. 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.

10. Signed study-specific consent form prior to study entry.

Exclusion Criteria:

1. Patients who have evidence of metastatic disease in the major viscera and/or
peritoneal seeding or ascites.

2. Previous irradiation to the planned field; or previous chemotherapy for pancreatic
cancer (Gemzar® or Taxol®).

3. Malignancy (within the past two years) except for non-melanomatous skin cancer or
carcinoma in situ of the cervix, uterus, or bladder.

4. Patients who have significant infection or other coexistent medical condition that
would preclude protocol therapy.