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Enzyme Inhibitor

Eflornithine + Sulindac for Colorectal Cancer Prevention (PACES Trial)

Phase 3
Recruiting
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.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

PACES 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.Check my eligibility
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.See study design
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.

PACES Trial 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.

PACES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Event rate, defined as rate of high-risk adenoma or second primary colorectal cancer (CRC)
Secondary outcome measures
Adenomas >= 1 cm
Adenoma
Baseline meat consumption
+12 more

PACES 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
260,471 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,671 Previous Clinical Trials
40,925,429 Total Patients Enrolled
Cancer Prevention Pharmaceuticals, Inc.Industry Sponsor
7 Previous Clinical Trials
442 Total Patients Enrolled

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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How does the use of Eflornithine plus sulindac compare to other treatments?

"Eflornithine plus sulindac was first studied in 2013 at Lake Norman Hematology Oncology Specialists-Mooresville. There have been 18 completed studies thus far. Currently, there are 14 clinical trials recruiting patients, with a high concentration of these studies taking place in O'Fallon, Illinois."

Answered by AI

How many patients are being used in this research?

"In order to carry out this clinical trial, 1340 patients that meet the inclusion criteria are needed. The sponsor, Cancer Prevention Pharmaceuticals, Inc., will be managing the trial from various centres, such as Cancer Care Center of O'Fallon in O'Fallon, Illinois, and OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center in Pekin, Michigan."

Answered by AI

To your knowledge, has this type of experiment been conducted before?

"As of now, there are 14 Eflornithine plus sulindac clinical trials taking place in 702 cities and 12 countries. The first trial of its kind was conducted in 2013 and, since then, 18 more have been completed. The original trial was sponsored by Cancer Prevention Pharmaceuticals, Inc. and had 1,340 participants. It completed its Phase 3 drug approval stage."

Answered by AI

Has the Eflornithine and sulindac combination been cleared by the FDA?

"Eflornithine combined with sulindac is considered to be safe (3 on a scale from 1-3) due to Phase 3 data supporting its efficacy and multiple rounds of safety data."

Answered by AI

In how many different geographic areas is this trial being conducted?

"To make things more convenient for participants, this clinical trial is running at 100 different locations. Some of these sites are in O'Fallon, Pekin, and Grosse Pointe Woods. By picking a location close to you, you can reduce the amount you need to travel."

Answered by AI

What are eflornithine and sulindac used for when taken together?

"Eflornithine in combination with sulindac is used to treat meningoencephalitic stage trypanosoma brucei gambiense infection. It is also an effective treatment for colorectal adenomas, acute subacromial bursitis, and osteoarthritis."

Answered by AI

Are researchers looking for new participants at this time?

"That is correct. The clinicaltrials.gov website shows that this research project is still recruiting patients. The study was first advertised on 2013-03-01 and was most recently updated on 2022-08-23. They are hoping to find 1340 people total from 100 different locations."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
Minnesota
California
How old are they?
18 - 65
What site did they apply to?
Parkland Memorial Hospital
Emory University Hospital/Winship Cancer Institute
M D Anderson Cancer Center
Other
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
1

Why did patients apply to this trial?

I am currently in remission from both Colan cancer and stage 4 pancreatic cancer and also have Neurofibromatosis.
PatientReceived no prior treatments

How responsive is this trial?

Typically responds via
Phone Call
Email
Most responsive sites:
  1. Hennepin County Medical Center: < 24 hours
  2. Southeastern Medical Oncology Center-Goldsboro: < 24 hours
  3. University Oncology Associates: < 24 hours
Average response time
  • < 1 Day
Recent research and studies
clinicaltrials.govStudy
S0820, Adenoma and Second Primary Prevention Trial
2013. "S0820, Adenoma and Second Primary Prevention Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01349881.
All > Colorectal Cancer San Diego > Paid Studies Maine
~265 spots leftby Feb 2027
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