This phase II trial studies how well pancrelipase works in managing body mass index in patients with pancreatic ductal adenocarcinoma (PDAC) that has spread from where it first started (primary site) to other places in the body (metastatic). People who have PDAC often develop exocrine pancreatic insufficiency (EPI). EPI occurs when the pancreas doesn’t make enough of the enzymes that the body needs to break down and absorb nutrients. EPI can lead to various health problems, including weight loss, nausea, indigestion, frequent oily/greasy bowel movements that have a lot of odor, and malnutrition (when the body doesn’t get the vitamins, minerals, and other nutrients it needs). EPI can also cause a decrease in patients’ quality of life. Pancrelipase contains a mixture of digestive enzymes that help the body break down and digest nutrients in food (such as fats, starch, and proteins). Pancrelipase may lead to needed weight gain and an improved quality of life in people with metastatic PDAC.
Additional locations may be listed on ClinicalTrials.gov for NCT05642962.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. Change in body mass index 4 months from baseline while on pancreatic enzyme replacement therapy (PERT).
SECONDARY OBJECTIVE:
I. Changes in patient-reported health related quality of life, adherence/compliance with PERT, toxicity assessment, duration of chemotherapy administered, and changes in fecal elastase.
EXPLORATORY OBJECTIVES:
I. Morphometric image analyses.
II. Changes in weight, microbiome, and serum metabolites/inflammatory markers.
III. Evaluating early treatment associated changes in imaging biomarkers derived from the qualitative and quantitative magnetic resonance imaging (MRI) data acquired at baseline and after 8 weeks during therapy.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients receive pancrelipase orally (PO) at a dosage of 384 IU/kg/meal on study while receiving standard of care (SOC) modified fluorouracil, irinotecan, leucovorin and oxaliplatin (FOLFIRINOX) (mFOLFIRINOX). Treatment repeats every 4 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of fecal and blood samples as well as computed tomography (CT) and may undergo positron emission tomography (PET) and/or MRI throughout the study.
ARM II: Patients receive pancrelipase PO at a dosage of 1350 IU/kg/meal on study while receiving SOC mFOLFIRINOX. Treatment repeats every 4 weeks for up to 5 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo collection of fecal and blood samples as well as CT and may undergo PET and/or MRI throughout the study.
After completion of study treatment, patients are followed up for up to 2 years from first dose of pancrelipase.
Lead OrganizationMemorial Sloan Kettering Cancer Center
Principal InvestigatorEileen M. O'Reilly
