The Prevention of Progression to Pancreatic Cancer Trial (The 3P-C Trial)

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

Summary

This is a multi-center randomized double-blind placebo controlled trial of patients with high-risk intraductal papillary mucinous neoplasms (IPMNs) of the pancreas. The primary objective is to evaluate the effect of sulindac on the presence or absence of progression of IPMN after 3 years of treatment.

Patients without contraindications will be considered to be eligible and will be required to have a cross-sectional imaging study of the pancreas (pancreas protocol CT or CT angiogram of the pancreas) within 3 months of study entry to document residual IPMNs and to rule out any evidence of pancreatic cancer. Patients will be randomized to receive either sulindac (200 mg p.o. BID) plus standard radiographic and endoscopic surveillance or placebo plus standard radiographic and endoscopic surveillance. Randomization will be stratified by (1) whether the patient had high-grade dysplasia identified in the initial resection specimen (resected patients only) and (2) whether the patient is taking metformin at the time of randomization.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Duke University
• Collaborators: Johns Hopkins University; Massachusetts General Hospital; Memorial Sloan Kettering Cancer Center; National Cancer Institute (NCI)
• Treatments: Sulindac

Criteria

Inclusion Criteria:

1. Subject is a man or woman between the ages of 21 and 85 years.

2. Subject has high-risk IPMN as defined below.

1. Patient has undergone partial pancreatectomy for non-invasive IPMN AND has residual cyst(s) > 1 cm

2. Patient has a radiographic lesion of the pancreas consistent with IPMN as documented by:

i. Cyst fluid CEA > 192 ng/ml OR MRI confirmation of communication with main pancreatic duct AND has any of the following worrisome features:

• Cyst > 3 cm

• Thickened/enhancing cyst walls

• Main pancreatic duct > 5mm

• Abrupt change in caliber of pancreatic duct with distal atrophy

3. Subjects has ECOG of 0-2

4. Subject is medically fit to undergo EUS.

5. Female subjects who are of childbearing potential or are capable of becoming pregnant must be willing to use appropriate methods of contraception for the length of the study.

6. Subject is able to provide written informed consent.

Exclusion Criteria:

1. Subject has pathologic evidence of pancreatic cancer.

2. Subject takes an NSAID 3 or more times per week.

3. Subject has a history of or currently has known allergy to NSAIDs or a contraindication to use of NSAIDs in the opinion of the treating investigator.

4. Subject has a history of gastric ulcer, non-iatrogenic intestinal perforation, gastrointestinal bleeding from NSAID use for which intervention was required, renal insufficiency (eGFR <60 mL/minute/1.73 m2), venous thromboembolism, cirrhosis, asthma, or any other condition that serves as a contraindication to the use of sulindac.

5. Myocardial infarction or coronary artery bypass grafting within six months of study entry.

6. Congestive Heart Failure.

7. Severe adverse drug reaction to iodinated contrast agents that cannot be managed with routine premedication prior to imaging.

8. Prior diagnosis or active treatment for (other) prior malignancy (except in situ cancers) within the previous 3 years.

9. History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as gastric bypass, prior total gastrectomy).

10. Subject is lactating or pregnant.