A Phase I/II Radiation Dose-Escalation Study of Intensity-Modulated Radiotherapy (IMRT) With Concurrent Gemcitabine in Patients With Unresectable Pancreatic Cancer

Inclusion Criteria:

- Is the patient 18 years of age or older.

- Does the patient have histologically or cytologically proven carcinoma of the
pancreas

- Is the tumor unresectable or medically inoperable

- Does the patient have a Zubrod performance status of ≤ 2 (appendix I).

- Does the patient have an absolute neutrophil count of ≥ 1500/mm3, and platelets ≥
100,000/mm3

- Does the patient have adequate renal function (creatinine < 2 mg/dl) and hepatic
function (bilirubin < 3 mg/dl), with relief of biliary obstruction if present

- Is the patient free of significant co-morbid conditions that would preclude safe
administration or completion of protocol therapy

- If the patient is of reproductive potential, has he or she agreed to use an effective
method of contraception during treatment on this trial and for 6 months after
treatment

- Is the patient aware of the investigational nature of the therapy such that they can
provide written informed consent

Exclusion Criteria:

- Does the patient have a neuroendocrine tumor of the pancreas

- Does the patient have metastatic disease

- Does the patient have a history of abdominal radiation therapy

- Is there history of more than 1 month of therapy with single agent gemcitabine

- Has the patient used any investigational agent in the month before enrollment into
the study