Pancrelipase in People With Pancreatic Ductal Adenocarcinoma (PDAC)

Launched by MEMORIAL SLOAN KETTERING CANCER CENTER · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how a medication called pancrelipase affects the body mass index (BMI) of people with advanced pancreatic cancer, specifically metastatic pancreatic ductal adenocarcinoma (PDAC). BMI is a measurement that helps determine if a person is underweight, healthy, overweight, or obese based on their height and weight. The trial will also look at two different ways to take pancrelipase and see how it works for patients who do not have symptoms of a condition known as EPI (exocrine pancreatic insufficiency), which can affect digestion.

To participate in this study, individuals must be at least 18 years old and have a confirmed diagnosis of pancreatic cancer that has spread to other parts of the body. They should be planning to receive a specific chemotherapy treatment called FOLFIRINOX and must not have used pancreatic enzyme replacement therapy in the two weeks before joining the trial. Participants should be able to swallow capsules and expect to sign an informed consent document. It's important to note that some patients, such as those with certain chronic illnesses or previous pancreatic surgery, may not be eligible. This trial is currently looking for participants, and those who join will help researchers understand the potential benefits of pancrelipase in managing their condition.

Gender

ALL

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.

Trial Officials