Study of Modified FOLFIRINOX in Advanced Pancreatic Cancer

Inclusion Criteria:

• Pathologic or cytologic documentation of pancreatic adenocarcinoma
• Metastatic or locally advanced unresectable disease, including borderline unresectable disease
• Patients with biliary or gastroduodenal obstruction must have drainage or surgical bypass prior to starting chemoradiation
• Measurable or non-measurable assessable disease
• No prior treatment (chemotherapy, biological therapy, or radiotherapy) for metastatic or non-metastatic locally advanced unresectable pancreatic cancer
• 6 months since completion of any prior neoadjuvant or adjuvant therapy (chemotherapy or radiotherapy) for resected pancreatic cancer
• No prior treatment with oxaliplatin or irinotecan
• No prior treatment with fluoruouracil or capecitabine unless administered as a radiosensitizing drug during adjuvant/neoadjuvant chemoradiotherapy after/before resection of pancreatic cancer
• Patients who received chemotherapy > 2 years ago for malignancies other than pancreatic cancer are eligible, provided that chemotherapy was completed > 2 years ago and there is no evidence of the second malignancy at the time of study entry
• > 4 weeks since major surgery
• No other concurrent anticancer therapy
• ECOG Performance Status: 0-1
• Age > 18
• No other malignancy within past two years except basal cell carcinoma of the skin, cervical carcinoma in situ, or nonmetastatic prostate cancer
• Paraffin block or slides must be available
• Adequate organ function
• No interstitial pneumonia or extensive and symptomatic interstitial fibrosis of the lung
• No > grade 1 sensory peripheral neuropathy
• No uncontrolled seizure disorder, active neurological disease, or known CNS disease
• No significant cardiac disease, including the following: unstable angina, New York Heart Association class II-IV congestive heart failure, myocardial infarction within six months prior to study enrollment
• No history of chronic diarrhea
• Not pregnant and not nursing
• No other medical condition or reason that, in the opinion of the investigator, would preclude study participation
• Laboratory parameters as follows: absolute neutrophil count ≥ 1,500/uL, platelet count ≥ 100,000/uL, hemoglobin ≥ 9 g,/dL, creatinine < 1.5 X ULN or estimated GFR > 30 ml/min, bilirubin < 1.5 X ULN, AST and ALT < 3 X ULN, negative pregnancy test in women of childbearing age