Pancreatic Cancer Clinical Trial
Official title:
A Randomized Double Blind Study of Pancreatic Enzyme Replacement Therapy for Patients With Metastatic Pancreatic Ductal Adenocarcinoma
The main purpose of this study is to see how pancrelipase affects the body mass index (BMI) in people with metastatic PDAC. BMI is a measure based on a person's height and weight. Other study goals are to explore two different dosing schedules of pancrelipase and to evaluate pancrelipase in people who do not have symptoms of EPI.
| Status | Recruiting |
| Enrollment | 40 |
| Est. completion date | November 30, 2024 |
| Est. primary completion date | November 30, 2024 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) | Basking Ridge | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center @ Suffolk - Commack (Limited Protocol Activities) | Commack | New York |
| United States | Memorial Sloan Kettering Westchester (Limited Protocol Activities) | Harrison | New York |
| United States | Memorial Sloan Kettering Monmouth (Limited Protocol Activities) | Middletown | New Jersey |
| United States | Memorial Sloan Kettering Bergen (Limited Protocol Activities) | Montvale | New Jersey |
| United States | Memorial Sloan Kettering Cancer Center | New York | New York |
| United States | Memorial Sloan Kettering Nassau (Limited Protocol Activities) | Uniondale | New York |
| Lead Sponsor | Collaborator |
|---|---|
| Memorial Sloan Kettering Cancer Center |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change in body mass index/BMI from baseline to 4 months | The primary objective is a change in body mass index (BMI) 4 months from baseline while on pancreatic enzyme replacement therapy (PERT). | 4 months |
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