A Phase II Study Induction Chemotherapy, Neoadjuvant Chemoradiotherapy, Surgical Resection and Adjuvant Chemotherapy for Patients With Locally Advanced, Resectable Pancreatic Adenocarcinoma

Inclusion Criteria:

- Patients must have histologically or cytologically confirmed diagnosis of localized,
resectable or borderline resectable, pancreatic adenocarcinoma T1-T3, N0-N1, M0;
stage is determined by helical multi-phase computed tomography (CT) and/or endoscopic
ultrasound according to published guidelines; resectability is determined by the
treating surgeon and published guidelines (National Comprehensive Cancer Network)

- Resectable Disease- Head/Body/Tail of pancreas:

- No distant metastases

- Clear fat plane around celiac and superior mesenteric arteries (SMA)

- Patent superior mesenteric vein (SMV) and portal vein (PV)

- Borderline Resectable Disease -Head/Body of pancreas:

- Tumor abutment on SMA

- SMV/portal vein impingement or occlusion if involving only a short segment, with
open vein both proximally and distally (if proximal vein is occluded up to the
portal vein branches then disease is unresectable)

- Colon or mesocolon invasion

- Gastroduodenal artery (GDA) encasement up to origin at hepatic artery

- Tail of pancreas:

- Adrenal, colon or mesocolon, or kidney invasion

- Preoperative evidence of biopsy-positive peripancreatic lymph node

- No prior therapy for pancreatic cancer

- Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)

- Leucocytes >= 3,000/uL

- Absolute Neutrophil Count >= 1,500/uL

- Platelets >= 100,000/uL

- Total Bilirubin:

- If within normal limits (WNL) to =< 2.0, the subject is eligible

- If > 2.0 - < 6.0, subject is eligible IF they have a biliary stent and total
bilirubin is decreasing

- If >= 6.0, subject is not eligible

- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) =<
2.5 X institutional upper limit of normal or =< 1.5 X upper limit of normal (ULN) if
alkaline phosphatase (Alk Phos) > 2.5 X ULN or if the subject has a biliary stent and
the liver function tests (LFTs) are decreasing the subject is eligible

- Creatinine clearance >= 30%

- Negative pregnancy test for women of childbearing potential; women of childbearing
potential and men must agree to use adequate contraception (hormonal or barrier
method of birth control; abstinence) prior to study entry and for the duration of
study participation; should a woman become pregnant or suspect she is pregnant while
participating in this study, she should inform her treating physician immediately

- Ability to swallow and retain oral medication

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

Exclusion Criteria:

- Patients may not be receiving any other investigational agents

- Histology other than adenocarcinoma

- Patients with permanently unresectable pancreatic adenocarcinoma as determined by the
treating physician and published guidelines (National Comprehensive Cancer Network
v2.2006

- Unresectable disease

- Head of pancreas:

- Distant metastases (includes celiac and/or para-aortic)

- SMA, celiac encasement

- SMV/portal occlusion

- Aortic, inferior vena cava (IVC) invasion or encasement

- Invasion of SMV below transverse mesocolon

- Body of pancreas:

- Distant metastases (includes celiac and/or para-aortic); at the discretion of
the treating surgeon, body and tail lesions that have positive celiac and/or
para-aortic nodes in close vicinity to the primary may be borderline rather than
unresectable

- SMA, celiac, hepatic encasement

- SMV/portal extended occlusion

- Aortic invasion

- Tail of pancreas:

- Distant metastases (includes celiac and/or para-aortic)

- SMA, celiac encasement

- Rib, vertebral invasion

- History of allergic reactions attributed to compounds of similar chemical or biologic
composition to gemcitabine, docetaxel, capecitabine, oxaliplatin or other agents used
in the study

- Patients who have received prior chemotherapy or radiotherapy for the diagnosis of
pancreatic cancer

- Uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements

- Inability to comply with study and/or follow-up procedures

- Pregnancy or lactation

- Human immunodeficiency virus (HIV)-positive patients receiving combination
anti-retroviral therapy