Sequential Neoadjuvant Chemotherapy for the Treatment of Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma

Inclusion Criteria

• Patients must have histologically or cytologically proven adenocarcinoma of the pancreas. Patients with mixed tumor with predominant adenocarcinoma pathology can be enrolled
• Patients with borderline resectable or locally advanced pancreatic adenocarcinoma as assessed per National Comprehensive Cancer Network (NCCN) guidelines (either pancreatic head, neck, uncinate process, or body/tail) or institutional multidisciplinary consensus
• Age 18 or above
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 - 1
• Hemoglobin >= 8 g/dL (It is acceptable to transfuse packed red blood cells [PRBC] and platelets at the time of enrollment to meet the eligibility criteria)
• Absolute neutrophil count >= 1,500/mcL
• Platelets >= 100,000/mcL (It is acceptable to transfuse packed red blood cells [PRBC] and platelets at the time of enrollment to meet the eligibility criteria)
• Total bilirubin =< 1.5 X institutional upper limit of normal * If obstructive jaundice is present, then biliary drainage must be initiated and total bilirubin ≤ 3.0
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase [SGOT]) / alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) < 2.5 X institutional upper limit of normal
• Creatinine =< 1.5 X institutional upper limit of normal or creatinine clearance (CrCL) > 50
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST version [v]1.1)
• Ability to understand and the willingness to sign an institutional review board (IRB)-approved informed consent document (either directly or via a legally authorized representative)

Exclusion Criteria

• Patients who have had prior chemotherapy with gemcitabine and/or nab-paclitaxel or FOLFIRINOX for pancreatic cancer
• Patients receiving any other investigational anti-neoplastic agents
• History of malignancy in last 3 years except cervical cancer in situ, adequately treated basal cell or squamous cell carcinoma of skin or treated low risk prostate cancer, who are considered to be eligible
• Patients with active and uncontrolled bacterial, viral or fungal infection requiring systemic therapy. Patients can be reevaluated for the study if the infection is deemed to be under control and the systemic therapy for the infection is completed
• Uncontrolled intercurrent illness including, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements or compromise the patient’s safety
• Patients with known diagnosis of interstitial lung disease, sarcoidosis, pulmonary fibrosis, or pneumonitis requiring oxygen supplementation. Those that do not require oxygen supplementation are eligible
• Patients who have undergone surgery, other than diagnostic or minor procedures, within 4 weeks prior to the initiation of study treatment
• Patients who are pregnant or breastfeeding