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Sulindac for Pancreatic Cancer Prevention

Phase 2

Waitlist Available

Led By Peter Allen, MD

Research Sponsored by Duke University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subject is a man or woman between the ages of 21 and 85 (inclusive) years.

Subjects has ECOG of 0-2

Must not have

Subject has pathologic evidence of pancreatic adenocarcinoma.

History of medical procedure that would prevent an endoscopic ultrasound from being performed (such as Roux-en-Y, prior total gastrectomy).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years

Summary

This trial is testing whether sulindac, an anti-inflammatory medication, can help prevent the progression of high-risk pancreatic growths in patients. The goal is to see if reducing inflammation can stop these growths from getting worse or turning into cancer. Sulindac is a promising treatment for chronic pancreatitis by reducing inflammation and tissue scarring.

Who is the study for?

This trial is for adults aged 21-85 with high-risk IPMN of the pancreas, who are medically fit for an endoscopic ultrasound and can undergo imaging studies. Women able to have children must use contraception during the study. Exclusions include heart failure, recent cancer treatments, certain surgical histories, severe drug reactions to contrast agents or NSAIDs, recent heart attacks or bypass surgery, and ongoing renal insufficiency or other conditions that conflict with sulindac use.

What is being tested?

The trial tests if sulindac (a nonsteroidal anti-inflammatory drug) can prevent progression of pancreatic lesions in patients with high-risk IPMNs compared to a placebo. Participants will receive either sulindac (400 mg daily) or a placebo alongside standard surveillance over up to three years. The process includes random assignment into groups considering prior dysplasia and metformin usage.

What are the potential side effects?

Potential side effects from sulindac may include gastrointestinal issues like ulcers and bleeding, allergic reactions especially in those sensitive to NSAIDs, kidney problems due to reduced function from long-term use, cardiovascular events such as heart attack or stroke risk increase.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 21 and 85 years old.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been diagnosed with pancreatic cancer.

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I have not had surgeries that would prevent an ultrasound through the esophagus.

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I have severe reactions to contrast dyes that can't be managed with normal pre-treatment.

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I have been diagnosed with congestive heart failure.

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I take steroids or NSAIDs more than three times a week.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percent of patients with IPMN progression as measured by a composite of several indicators

Secondary study objectives

Percent of patients with cyst progression as measured by radiographic images

Other study objectives

Percent of patients with Inflammatory Marker Progression

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SulindacExperimental Treatment1 Intervention

Patients will be randomized to receive standard radiographic/endoscopic surveillance plus sulindac. The sulindac starting dose is 200 mg by mouth 2x daily. Patients will continue drug for 3 years during follow-up.

Group II: PlaceboPlacebo Group1 Intervention

Patients will be randomized to receive standard radiographic/endoscopic surveillance plus placebo. Patients will continue placebo for 3 years during follow-up.

0 / 7Eligibility criteria met