Perioperative Therapy for Resectable Pancreatic Cancer

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 = = 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 - = 6.0, subject is not eligible
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT)(serum glutamate pyruvic transaminase [SGPT]) = 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)
• 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

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