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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.
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
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 belowSelect...
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.
Select...
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:Select...
I have had surgery to remove more than 40 cm of my colon.
Select...
My cancer is in the lower part of my rectum.
Select...
My cancer has returned or spread to other parts of my body.
Select...
I have a high risk of heart problems and my high blood pressure is not under control.
Select...
I am scheduled for more chemotherapy or radiation therapy.
Select...
I have had a stomach or upper small intestine ulcer in the past year.
Select...
I have a family history of specific colon conditions or have inflammatory bowel disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 8 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
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 moreTrial 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
13,868 Previous Clinical Trials
41,009,497 Total Patients Enrolled
Cancer Prevention Pharmaceuticals, Inc.Industry Sponsor
7 Previous Clinical Trials
442 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.It has been over 30 days since I finished my last chemotherapy and radiation therapy.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.I have a family history of specific colon conditions or have inflammatory bowel disease.I have had surgery to remove more than 40 cm of my colon.My recent scans after surgery show no signs of cancer.I can take pills by mouth.My cancer is in the lower part of my rectum.You are allergic to sulindac or any of its ingredients. You have had asthma, hives, or an allergic reaction to aspirin or other pain relievers.I don't have uncontrolled high cholesterol or blood pressure.I am not regularly taking steroids, NSAIDs, or blood thinners, except for low-dose aspirin or inhaled steroids for asthma.It has been over 30 days since I finished my last chemotherapy and radiation therapy.My cancer has returned or spread to other parts of my body.I do not have serious heart conditions or recent major heart events.I do not have uncontrolled high cholesterol or blood pressure.My acid reflux is under control with medication.I do not have serious heart problems or recent major heart events.I have no cancer history except for certain skin cancers, in situ cervical cancer, or any cancer I've been free of for over 5 years.My recent scans after surgery show no signs of cancer.I am 18 or older and mostly active without needing care.
Research Study Groups:
This trial has the following groups:- Group 1: Eflornithine plus sulindac
- Group 2: Eflornithine & sulindac placebo
- Group 3: Eflornithine placebo & sulindac
- Group 4: eflornithine placebo & sulindac placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT01349881 — Phase 3
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