Perioperative Therapy for Resectable Pancreatic Cancer

This is an interventional treatment trial for Adenocarcinoma of the Pancreas Read More

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 glutamate 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)
• 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