Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas

If subjects are eligible and wish to enroll in the study, they will begin chemotherapy
treatment with Gemcitabine and Abraxane. After subjects have received treatment with these
drugs, they will have surgery. Subjects will also have post treatment and follow up
evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects
will be followed every 3 months for 3 years after their initial registration.

Inclusion Criteria:

- Patient has histologically or cytologically confirmed potentially resectable
adenocarcinoma of the pancreas including tumors in the pancreatic head, uncinate
process, neck, body and tail that are potentially resectable by
pancreatico-duodenectomy (Kausch-Whipple procedure). Patients with islet cell or
other neuroendocrine neoplasms are excluded.

- Definition of localized, potentially resectable disease:

- Staging by intravenous contrast-enhanced thin section helical abdominal computed
tomography (2.5 mm cuts or less) or MRI (for patients with an IV contrast allergy)
using pancreatic protocol. Endoscopic ultrasound is required for tissue acquisition
and staging confirmation.

- No extension to superior mesenteric artery (SMA) and hepatic artery. Patent superior
mesenteric vein/portal vein (SMV/PV) with < 180-degree abutment and no evidence of
invasion.

- Clear fat plane between the SMA and celiac axis.

- No extension to celiac axis and hepatic artery.

- Patent superior mesenteric vein and portal vein.

- No evidence of distant disease.

- Male or non-pregnant and non-lactating female, and ≥ 18 years of age.

- If a female patient is of childbearing potential, she must have a negative serum
pregnancy test documented within 72 hours of the first administration of study drug.

- If sexually active, the patient must agree to use contraception considered adequate
and appropriate by the Investigator.

- Patient must not have received prior chemotherapy or radiation for pancreatic cancer.

- Patient has the acceptable blood counts as outlined in the protocol.

- Patient has an ECOG performance status PS 0-2.

- Patient has been informed about the nature of the study, and has agreed to
participate in the study, and signed the Informed Consent Form prior to participation
in any study-related activities.

Exclusion Criteria:

- Patient has borderline resectable, locally advanced unresectable or advanced
metastatic disease. Patients with adenocarcinoma of the distal pancreatic body or
tail are ineligible. Patients with endocrine tumors, lymphoma of the pancreas, or
ampullary cancer are also ineligible.

- Patient has active, uncontrolled bacterial, viral, or fungal infection(s) requiring
systemic therapy.

- Patient has known infection with HIV.

- Patient has undergone major surgery, other than diagnostic surgery (i.e.surgery done
to obtain a biopsy for diagnosis without removal of an organ), within 4 weeks prior
to Day 1 of treatment in this study.

- Patient has a history of allergy or hypersensitivity to the study drugs.

- Patient has serious medical risk factors involving any of the major organ systems
such that the Investigator considers it unsafe for the patient to receive
chemotherapy and/or radiation therapy.

- Patients requires chronic use of immunosuppressive agents (e.g. methotrexate,
cyclosporine).

- No other prior malignancy is allowed except for the following: adequately treated
basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated
Stage I or II cancer from which the patient is currently in complete remission, or
any other cancer from which the patient has been disease-free for five years.

- Patients must not have clinically significant cardiovascular disease (including
myocardial infarction, unstable angina, symptomatic congestive heart failure, serious
uncontrolled cardiac arrhythmia) < 1 year before randomization.

- Patient is unwilling or unable to comply with study procedures.

- Patient is enrolled in any other therapeutic clinical protocol or investigational
trial.

- Patients aged ≥ 80 are not excluded. However, candidates in this age group should be
thoroughly evaluated before enrollment in the study, to ensure they are fit to
receive chemotherapy, and to potentially undergo pancreaticoduodenectomy. In addition
to meeting all of the baseline patient selection criteria, clinical judgment on their
susceptibility to infection and expected stability of their performance status and
suitability to receive intensive chemotherapy cycles, should be paid special
attention to. Patients should not be enrolled in the study should there be any
hesitation on any of these considerations. Baseline criteria for all patients
enrolled on the study must be carefully evaluated and all criteria followed
appropriately.