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Enzyme Inhibitor

Eflornithine + Sulindac for Colorectal Cancer Prevention (PACES Trial)

Phase 3
Waitlist Available
Led By Jason A. Zell, D.O., MPH
Research Sponsored by Southwest Oncology Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease
Must not have cardiovascular risk factors including unstable angina, history of myocardial infarction, or cerebrovascular accident, coronary artery bypass surgery, or NY Heart Assoc Class III or IV heart failure.
Must not have
History of colon resection > 40 cm
Mid-low rectal cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights
Pivotal Trial

Summary

This trial will test a combination of drugs to see if they are effective in reducing the chance of cancer recurrence or developing new cancers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Possible side effects include digestive issues like ulcers (for those taking sulindac), hearing loss (eflornithine has been linked to this in some cases), allergic reactions if sensitive to NSAIDs, and general medication-related risks such as liver function changes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My recent scans after surgery show no signs of cancer.
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I do not have serious heart conditions or recent major heart events.
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I do not have uncontrolled high cholesterol or blood pressure.
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I am not regularly taking steroids, NSAIDs more than 10 days a month, or blood thinners.
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My recent scans after surgery show no signs of cancer.
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I do not have serious heart problems or recent major heart events.
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I don't have uncontrolled high cholesterol or blood pressure.
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I can take pills by mouth.
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I am 18 or older and mostly active without needing care.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to remove more than 40 cm of my colon.
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My cancer is in the lower part of my rectum.
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My cancer has returned or spread to other parts of my body.
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I have a high risk of heart problems and my high blood pressure is not under control.
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I am scheduled for more chemotherapy or radiation therapy.
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I have had a stomach or upper small intestine ulcer in the past year.
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I have a family history of specific colon conditions or have inflammatory bowel disease.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 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
Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)
Secondary study objectives
Adenomas >= 1 cm
Adenoma
Baseline meat consumption
+12 more

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Eflornithine plus sulindacExperimental Treatment1 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 & sulindacExperimental Treatment1 Intervention
Eflornithine placebo 2 tablets PO daily for 3 years. Sulindac one 150 mg tablet PO daily for 3 years.
Group III: Eflornithine & sulindac placeboExperimental Treatment1 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 placeboPlacebo Group1 Intervention
Eflornithine placebo 2 tablets, PO, daily for 3 years. Sulindac placebo, 1 tablet, PO, daily for 3 years.

Find a Location

Who is running the clinical trial?

Southwest Oncology GroupLead Sponsor
388 Previous Clinical Trials
259,847 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,957 Previous Clinical Trials
41,111,733 Total Patients Enrolled
Cancer Prevention Pharmaceuticals, Inc.Industry Sponsor
7 Previous Clinical Trials
442 Total Patients Enrolled
SWOG Cancer Research NetworkLead Sponsor
398 Previous Clinical Trials
265,262 Total Patients Enrolled
Jason A. Zell, D.O., MPHPrincipal InvestigatorUniversity of California, Irvine

Media Library

Eflornithine (Enzyme Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01349881 — Phase 3
Colorectal Cancer Research Study Groups: Eflornithine plus sulindac, Eflornithine & sulindac placebo, Eflornithine placebo & sulindac, eflornithine placebo & sulindac placebo
Colorectal Cancer Clinical Trial 2023: Eflornithine Highlights & Side Effects. Trial Name: NCT01349881 — Phase 3
Eflornithine (Enzyme Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01349881 — Phase 3
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT01349881 — Phase 3
~55 spots leftby Feb 2027
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