Phase II Study of Chemo-Radiotherapy in Patients With Resectable and Borderline Resectable Pancreatic Cancer

The primary objective is to evaluate frequency of achieving complete resection ( RO
resection )in patients with resectable and borderline resectable pancreatic cancer treated
with a neoadjuvant regimen of FOLFOX followed by radiation therapy (RT) concurrent with
gemcitabine chemotherapy at standard dosing.

Secondary objectives are to determine overall survival and progression-free survival as a
function of time from study enrollment and to evaluate tolerability and toxicity of protocol
treatment.

Eligible patients with resectable and borderline resectable pancreatic cancer will be
accrued onto protocol therapy, which would include a neo-adjuvant phase followed by surgical
resection. A cycle of FOLFOX treatment is 14 days. 2 cycles are intended prior to combined
modality treatment. Combined modality treatment will begin 2 weeks (plus or minus 2 days)
after the last FOLFOX administration. (Gemcitabine 1000mg/m² will be infused over 30 minutes
on days 1, 8, 22, and 29 during the 5-week course of radiation treatment. The surgical
procedure performed will be that required for a complete resection, and this will be based
on the discretion of the operating surgeon. Patients will be followed for 1 year after
completion of neoadjuvant therapy or until removal or termination from study, or until
death, whichever occurs first. Patients will be seen in follow-up ever 3+/- 1 months for 1
year from completion of protocol therapy.

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed pancreatic
adenocarcinoma of the pancreatic head or body

- Patients must have radiographically-confirmed surgically resectable or borderline
resectable disease at study entry staged at T1-3, NO-1 and MO

- Age >/= 18years

- Life expectancy of greater than 6 months in the opinion of the investigator,
excluding theh pancreatic cancer

- Eastern Cooperative Oncology Group (ECOG) performance status
- Required laboratory data (see protocol)

- Disease assessment by CT scan within 4 weeks of study entry

- Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

- Patients may not be receiving any other investigational agent

- Patients with metastatic disease are excluded from this clinical trial

- History of allergic reactions attributed to Fluorouracil (5FU), oxaliplatin and
gemcitabine

- No prior chemotherapy or radiation therapy for pancreatic cancer (previous
chemotherapy or radiation therapy for other malignancies is permitted)

- Patients with uncontrolled hypocalcemia, hypomagnesemia, hyponatremia,
hypophosphatemia or hypokalemia defined as less than the lower limit of normal for
the institution, despite adequate electrolyte supplementation are excluded from this
study.

- Uncontrolled serious intercurrent illness including, but not limited to, ongoing or
serious active infection requiring IV antibiotics for over 30 days, symptomatic
congestive heart failure, unstable angina pectoris, cardiac arrhythmia other than
chronic, stable atrial fibrillation, or psychiatric illness/social situations that
would limit compliance with study requirements

- Pregnant or breastfeeding women are excluded from this study.

- Known HIV-positive patients are ineligible

- Patients with unresectable disease are excluded form the protocol (see Appendix B for
National Comprehensive cancer Network [NCCN] criteria for determining resectability
status). Surgical resectability must be confirmed by a surgeon experienced in
pancreatic surgery.

- Patients with pancreatic tail lesions will be excluded