Sulindac for Pancreatic Cancer Prevention

Not currently recruiting at 3 trial locations

Overseen By Peter Allen, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Duke University

Must not be taking: Corticosteroids, NSAIDs

Disqualifiers: Pancreatic adenocarcinoma, Renal insufficiency, Cardiovascular disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

Duration: 3 years

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if sulindac, a type of medication, can prevent the progression of certain pre-cancerous growths in the pancreas called intraductal papillary mucinous neoplasms (IPMNs). Participants will receive either sulindac or a placebo, with regular monitoring through scans and endoscopies, for up to three years. The trial seeks individuals diagnosed with high-risk IPMN, which may include features like larger cysts or changes in the pancreatic duct. As a Phase 2 trial, this research measures how well sulindac works in an initial, smaller group of people, offering a chance to contribute to important advancements in pancreatic health.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but you cannot participate if you take a systemic corticosteroid or NSAID more than 3 times a week. If you are on these medications, you may need to stop or reduce them to join the trial.

Is there any evidence suggesting that sulindac is likely to be safe for humans?

Research has shown that sulindac has been safely used in clinical trials for various health issues. While specific safety information for its use in preventing pancreatic cancer is not available, its use in other trials suggests it is generally safe. Most people taking sulindac do not experience serious side effects. However, some might encounter mild side effects. Discussing potential risks with a doctor is important before joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for pancreatic cancer prevention?

Unlike the standard treatments for pancreatic cancer, which typically involve chemotherapy and radiation, sulindac is being explored for its potential to prevent pancreatic cancer altogether. Sulindac is a nonsteroidal anti-inflammatory drug (NSAID) that may work differently by reducing inflammation, which is thought to play a role in cancer development. Researchers are excited because if sulindac proves effective, it could offer a proactive approach to cancer prevention, potentially reducing the need for more aggressive treatments later on.

What evidence suggests that sulindac might be an effective treatment for pancreatic cancer prevention?

Research has shown that sulindac, a drug that reduces inflammation, might help prevent pancreatic cancer. Studies in mice found that sulindac can slow the growth of pancreatic tumors by affecting a specific protein linked to cancer. Additionally, sulindac has prevented cells from becoming cancerous, suggesting it might lower the risk of pancreatic cancer in people with certain pancreatic growths. This trial will compare sulindac with a placebo to evaluate its effectiveness in humans. While these early results are promising, human trials are needed to confirm its efficacy. ^{1 2 3 6 7}

Who Is on the Research Team?

Peter Allen, MD

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I am between 21 and 85 years old.

I am willing to use birth control during the study.

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

Exclusion Criteria

I have been diagnosed with pancreatic cancer.

You have a history of severe allergic reactions to NSAIDs or aspirin, or have had stomach ulcers or bleeding from using NSAIDs.

I have kidney, heart, or stomach issues that may prevent me from taking certain medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

3 months

1 visit (in-person)

Treatment

Participants receive sulindac or placebo twice daily for up to 3 years with regular assessments

3 years

Bi-annual visits (in-person), bi-monthly phone calls

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

Annual imaging and EUS assessments

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• Sulindac

Trial Overview

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.

How Is the Trial Designed?

Group I: Sulindac Experimental Treatment 1 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: Placebo Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Johns Hopkins University

Collaborator

Trials

2,366

Recruited

15,160,000+

Massachusetts General Hospital

Collaborator

Trials

3,066

Recruited

13,430,000+

Memorial Sloan Kettering Cancer Center

Collaborator

Trials

1,998

Recruited

602,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3765049/

Sulindac inhibits pancreatic carcinogenesis in LSL-KrasG12D ...

Our results demonstrate that sulindac inhibits pancreatic carcinogenesis by the inhibition of Kras protein prenylation by targeting AKR1B10.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04207944

The Prevention of Progression to Pancreatic Cancer Trial ...

The primary objective is to evaluate the effect of sulindac on the presence or absence of progression of IPMN after up to 3 years of treatment.

3.

withpower.com

withpower.com/trial/phase-3-pancreatic-intraductal-neoplasms-6-2020-ff7a0

Sulindac for Pancreatic Cancer Prevention

This trial is testing whether sulindac, an anti-inflammatory medication, can help prevent the progression of high-risk pancreatic growths in patients.

4.

aacrjournals.org

aacrjournals.org/mct/article/6/6/1736/235868/Suppression-of-pancreatic-tumor-growth-by

Suppression of pancreatic tumor growth by combination ...

High-dose sulindac alone and low-dose combination treatment with LC-1/sulindac effectively suppressed pancreatic tumor growth. Ki-67 and CD31 staining were ...

5.

dukecancerinstitute.org

dukecancerinstitute.org/blogs/allen-leads-nih-funded-pancreatic-cancer-prevention-trial

Allen Leads NIH-Funded Pancreatic Cancer Prevention Trial

And the drug has proven to be highly effective at preventing a progression to malignancy in pre-clinical (mouse) models. Allen is hoping that ...

6.

acsjournals.onlinelibrary.wiley.com

acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.70035

Advances in pancreatic cancer early diagnosis, prevention ...

Yet, even in the context of clinical trials, the median overall survival for patients with metastatic PDAC remains less than 1 year. Furthermore ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3898803/

Phospho-sulindac inhibits pancreatic cancer growth

Sulindac 1.0×IC50 reduced BrdU(+) cells by 70.3%, 20% less in comparison to P-S 1.0×IC50. These results show that while both P-S and sulindac are able to ...