Eflornithine + Sulindac for Colorectal Cancer Prevention

(PACES Trial)

Recruiting at1010 trial locations

Overseen by Jason A. Zell

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Southwest Oncology Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that the combination of eflornithine and sulindac will be effective in reducing a three-year event rate of adenomas and second primary colorectal cancers in patients previously treated for Stages 0 through III colon or rectal cancer.

Research Team

Jason A. Zell

Principal Investigator

University of California, Irvine

Eligibility Criteria

This trial is for adults who've had Stage 0-III colon or rectal cancer and completed surgery a year ago, with no current evidence of disease. They must have finished chemo and radiation at least 30 days prior, be able to swallow pills, not take certain drugs regularly (like NSAIDs), and have stable vital signs. Pregnant women or those with high cardiovascular risks are excluded.

Inclusion Criteria

I had surgery for colon or rectal cancer that was stage 0-III, over a year ago.

I am not regularly taking steroids, NSAIDs more than 10 days a month, or blood thinners.

I had surgery for colon or rectal cancer that was stage 0-III, over a year ago.

Exclusion Criteria

I have a high risk of heart problems and my high blood pressure is not under control.

I am scheduled for more chemotherapy or radiation therapy.

I have had a stomach or upper small intestine ulcer in the past year.

Treatment Details

Interventions

• Eflornithine (Enzyme Inhibitor)
• Sulindac (Nonsteroidal Anti-inflammatory Drug)

Trial Overview The study tests if eflornithine combined with sulindac can prevent the return of adenomas or colorectal cancers in patients previously treated for these conditions. Participants will receive either both drugs, one drug plus a placebo, or double placebos over three years.

Participant Groups

Group I: Eflornithine plus sulindac Experimental Treatment 1 Intervention

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Group II: Eflornithine placebo & sulindac Experimental Treatment 1 Intervention

Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.

Group III: Eflornithine & sulindac placebo Experimental Treatment 1 Intervention

Eflornithine two 250 mg tablets PO daily for 3 years. Sulindac placebo one tablet PO daily for 3 years.

Group IV: eflornithine placebo & sulindac placebo Placebo Group 1 Intervention

Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.

Who Is Running the Clinical Trial?

Southwest Oncology Group

Lead Sponsor

Trials

389

Recruited

260,000+

Dr. Lyudmila Bazhenova

Southwest Oncology Group

Chief Medical Officer since 2021

MD from University of California, San Diego

Dr. Richard Schilsky

Southwest Oncology Group

Chief Executive Officer since 2013

MD from University of California, San Diego

SWOG Cancer Research Network

Lead Sponsor

Trials

403

Recruited

267,000+

Dr. Charles D. Blanke

SWOG Cancer Research Network

Chief Executive Officer since 2012

MD from Oregon Health & Science University

Dr. Dawn Hershman

SWOG Cancer Research Network

Chief Medical Officer since 2020

MD from Columbia University

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

Cancer Prevention Pharmaceuticals, Inc.

Industry Sponsor

Trials

8

Recruited

800+