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Eflornithine + Sulindac for Adenoma Prevention(PACES Trial)
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.
- Colorectal Cancer
PACES Trial Eligibility Criteria
Inclusion CriteriaYou will be eligible if you check “Yes” for the criteria below
PACES Trial Timeline
Study ObjectivesOutcome measures can provide a clearer picture of what you can expect from a treatment.
Awards & Highlights
PACES Trial Design
Find a Location
Who is running the clinical trial?
- You have a condition called gastroesophageal reflux disease (GERD), but it's under control with medication.You have a family history of certain types of colon cancer or ongoing bowel inflammation.You cannot take regular intravenous corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs), or anticoagulants. You can use inhaled steroids for asthma or related conditions, but NSAIDs should not be used for more than 10 days per month. If you take aspirin, the maximum dose is 100mg per day or two 325mg tablets per week.Your disease has come back or spread to other parts of your body.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.Post-operative colonoscopy and CT scans of chest, abdomen & pelvis showing no evidence of disease.You have completed adjuvant chemo and RT.You have rectal cancer located in the middle or lower part of your rectum.You are planning to have radiation therapy or additional chemotherapy during the study period.You are not currently taking, or planning to take, intravenous corticosteroids, regular anticoagulants, or nonsteroidal anti-inflammatory drugs (NSAIDs) on a regular basis. If you do take NSAIDs, it cannot exceed 10 days per month, and you cannot take more than the maximum dose of aspirin.You have had a surgery to remove a significant length of your colon (more than 40 cm).
- Group 1: Eflornithine & sulindac placebo
- Group 2: Eflornithine placebo & sulindac
- Group 3: Eflornithine plus sulindac
- Group 4: eflornithine placebo & sulindac placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Frequently Asked Questions
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."
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, Michiganon, Illinois, and OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center in Pekin, Michigan."
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What site did they apply to?
What portion of applicants met pre-screening criteria?
How many prior treatments have patients received?
Why did patients apply to this trial?
How responsive is this trial?
Typically responds via
Most responsive sites:
- Hennepin County Medical Center: < 24 hours
- Southeastern Medical Oncology Center-Goldsboro: < 24 hours
- University Oncology Associates: < 24 hours
Average response time
- < 1 Day
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