FOLFIRINOX Chemotherapy Before Surgery in Treating Patients with Non-Metastatic Pancreatic Cancer

Inclusion Criteria

• Written informed consent obtained to participate in the study and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information.
• Histologically or cytologically confirmed adenocarcinoma of the pancreas with no evidence of distant metastatic disease.
• Subject has no evidence of co-morbidities precluding the potential to undergo surgical resection of PDAC as determined by surgical investigator.
• Subjects must be willing to undergo a mandatory pre- and post-treatment endoscopic ultrasound (EUS) guided core biopsy of the pancreatic mass.
• Measurable or non-measurable but evaluable (as determined by Response Evaluation Criteria in Solid Tumors version 1.1 [RECIST 1.1]) resectable, borderline resectable or unresectable locally advanced PDAC.
• Subject scheduled to receive FOLFIRINOX
• Subject has received no prior chemotherapy or chemoradiotherapy for pancreatic cancer. Subjects have not previously received surgery to remove pancreatic cancer.
• Age >= 18 years of age
• Subject has life expectancy of at least 6 months.

Exclusion Criteria

• Subject has any evidence of local recurrence or metastatic pancreatic cancer.
• Other malignancies within the past 5 years except for adequately treated cervical or vulvar carcinoma in situ, treated basal cell carcinoma, superficial bladder tumors (Ta, Tis and T1).
• Subject has hypersensitivity to fluorouracil (5FU), oxaliplatin or other platinum agent, or irinotecan or to their excipients.
• Subject has known dihydropyrimidine dehydrogenase (DPD) enzyme deficiency.
• Participation in any investigational drug study within 4 weeks preceding the start of FOLFIRINOX. Subjects are not permitted to participate in another investigational drug study while being treated on this protocol.
• Subject has current evidence of any condition that makes participating in this study not in the best interest of the subject.
• Subject has a history of or suspected Gilbert’s syndrome or known homozygosity for UGT1A1*28 polymorphism (baseline testing not required).
• Subject has sensory peripheral neuropathy grade >= 2.
• Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
• Subject is pregnant or lactating.
• Psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be discussed with the subject before registration in the trial.