Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)
Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Metastatic Pancreatic Adenocarcinoma
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Ductal Adenocarcinoma focused on measuring Metastatic Pancreatic Ductal Adenocarcinoma, Metastatic Pancreatic Cancer, Pancrelipase, Memorial Sloan Kettering Cancer Center, 21-419
Eligibility Criteria
Inclusion Criteria: Histopathologic or cytologic diagnosis of pancreatic adenocarcinoma, or adenosquamous cancer, or any non-neuroendocrine primary pancreas variant, including acinar cancer. De novo or recurrent diagnosis of previously untreated stage IV PDAC with intent to receive FOLFIRINOX/mFOLFIRINOX. ECOG 0-2. No use of pancreatic enzyme replacement therapy within prior 2 weeks. Patients with biliary obstruction are eligible provided biliary stenting has or will occur before treatment with FOLFIRINOX. Ability to understand and the willingness to sign an informed consent document. Ability to swallow capsules. Age ≥18 years. Anticipated life expectancy of at least 6 months. Exclusion Criteria: Chronic illness associated with malabsorption (celiac disease, cystic fibrosis, chronic pancreatitis, Crohn's disease). Fibrosing colonopathy. Prior history of surgical resection of the pancreas or gastric bypass. History of allergic reactions attributed to compounds of similar chemical or biologic composition to Pancrelipase. Patients cannot receive radiation, IRE, or other localized therapy directed to the pancreas while on study.
Sites / Locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Recruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Memorial Sloan Kettering Nassau (Limited Protocol Activities)Recruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm 1
Arm 2
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 384 units lipase/kg of body weight per meal or snack
Participants with stage 4 Pancreatic Ductal Adenocarcinoma / PDAC will receive 1350 units lipase/kg of body weight per meal or snack