This phase II trial studies the effect of sulindac in preventing progression to pancreatic cancer in patients with intraductal papillary mucinous neoplasms (IPMN). Sulindac, a non-steroidal, anti-inflammatory drug (NSAID), may help keep pancreatic cancer from forming in patients with IPMN.
Additional locations may be listed on ClinicalTrials.gov for NCT04207944.
See trial information on ClinicalTrials.gov for a list of participating sites.
PRIMARY OBJECTIVE:
I. To evaluate the effect of sulindac on the presence or absence of progression of intraductal papillary mucinous neoplasms (IPMN) after 3 years of treatment.
SECONDARY OBJECTIVE:
I. To quantitatively assess radiographic changes associated with progression.
EXPLORATORY OBJECTIVE:
I. To evaluate the ability of cyst fluid inflammatory marker analysis to identify progression.
OUTLINE: Patients are randomized to 1 of 2 arms.
ARM I: Patients undergo standard of care endoscopic ultrasound annually. Patients also receive sulindac orally (PO) twice daily (BID) for 3 years in the absence of disease progression or unacceptable toxicity
ARM II: Patients undergo standard of care endoscopic ultrasound annually. Patients also receive placebo PO BID for 3 years in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 3 years.
Lead OrganizationDuke University Medical Center
Principal InvestigatorPeter John Allen
