Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
Pilot, Neoadjuvant Gemcitabine and Abraxane Chemotherapy Followed by Surgery, Adenocarcinoma of the Pancreas
This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this
 research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and
 Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will
 have screening tests to determine if he or she is eligible to participate in this study.
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.