A Study of the Safety and Activity of Liposomal Irinotecan in Combination With the 5-FU and Oxaliplatin in the Preoperative Treatment of Pancreatic Adenocarcinoma

Exclusion Criteria

• •A medical history of prior anti-cancer treatment for pancreatic cancer.
• •Locally advanced unresectable disease or evidence of metastatic disease.
• •Any other invasive malignancy within the past three years.
• •Presence of any known contraindications to or hypersensitivities to the investigational products.
• •Use of strong CYP3A4 inhibitors or inducers which cannot be discontinued prior to study entry.
• •A non-surgical candidate.
• •Subject is unable to understand, provide consent or comply with study requirements, treatments or instructions in the opinion of the treating physician.
• •Uncontrolled diarrhea, active infection, known interstitial lung disease or other medical condition that precludes safe administration of this combination therapy consistent with manufacturer recommendations.
• •Unwilling/unable to comply with birth control requirements while on study.
• •Females or males of childbearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 7 months for females and 4 months for males after the last dose of study drug.
• •Females who are pregnant or breastfeeding.
• •History of any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of protocol therapy or that might affect the interpretation of the results of the study or that puts the subject at high risk for treatment complications, in the opinion of the treating physician.
• •Prisoners or subjects who are involuntarily incarcerated.
• •Subjects who are compulsorily detained for treatment of either a psychiatric or physical illness.
• •Subjects demonstrating an inability to comply with the study and/or follow-up procedures.
• •Known dihydrypyrimidine (DPD) deficiency