Sequential Neoadjuvant Chemotherapy for Borderline Resectable and Locally Advanced Pancreatic Adenocarcinoma
The objective of this research is to find out what effects (good and bad), the sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX, the standard chemotherapy for pancreatic cancer, has on participants and their condition. Gemcitabine - Abraxane (nab-Paclitaxel) and mFOLFIRINOX has been approved by the US Food and Drug Administration (FDA) as first line treatment for advanced pancreatic cancer. The sequence of Gemcitabine - Abraxane (nab-Paclitaxel) followed by mFOLFIRINOX has not been approved by the FDA for treatment of pancreatic cancer.
• 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.
• Patients must have organ and marrow function as defined below:
‣ Hemoglobin ≥8 g/dL
⁃ Absolute neutrophil count ≥1,500/mcL
⁃ Platelets ≥100,000/mcL
⁃ Total bilirubin ≤1.5 X institutional upper limit of normal
⁃ AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
⁃ Creatinine ≤1.5 X institutional upper limit of normal or CrCL\>50
⁃ It is acceptable to transfuse packed red blood cells (PRBC) and platelets at the time of enrollment to meet the eligibility criteria.
⁃ If obstructive jaundice is present, consider ursodiol or a biliary drainage procedure. If the total bilirubin can be reduced or kept to less than or equal to 3 mg/dL, then this inclusion criteria is met.
• Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
• Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).