National Colon Cancer Prevention Clinical Trial - Seeking Participants
Seeking Men and Women Who Have Had Colon Cancer for a National Colon Cancer Prevention Trial
Purpose: To determine if the drug, eflornithine and the drug, sulindac, taken alone or in combination, can prevent the occurrence of high-risk colorectal polyps and new colorectal cancers in patients with previously treated colon cancer. People who have had colon cancer have a greater than average risk of developing polyps in the colon and rectum, which may become colon cancer in the future. Preventing polyps may reduce the risk of a new colon cancer.
You may be eligible if you:
➢ have had stage 0, I, II, or III colon cancer,
➢ had surgery for that colon cancer within the past 9 – 15 months,
➢ have completed any chemotherapy you may have had, and
➢ are now cancer-free.
There are other eligibility requirements as well. Your study doctor or research nurse can review them to determine if you are eligible.
WHAT DOES THE STUDY INVOLVE?
If you join the trial, you will be assigned at ran¬dom to one of four study groups, or arms. You have a fair and equal chance of being placed into:
• eflornithine 2 tablets daily plus sulindac 1 tablet daily or
• placebo for eflornithine 2 tablets daily plus sulindac 1 tablet daily or
• eflornithine 2 tablets daily plus placebo for sulindac 1 tablet daily or
• placebo for eflornithine 2 tablets daily plus placebo for sulindac 1 tablet daily.
The study drugs will be supplied free of charge and you will take them for three years.
WHY EFLORNITHINE AND SULINDAC?
Sulindac is a nonsteroidal, anti-inflammatory pain reliever commercially available but is not approved for this use. Eflornithine is an investigational drug currently not available outside of the clinical trial setting in the U.S. Eflornithine slows the production of a group of naturally-formed molecules called polyamines. Excess polyamines have a role in the development of colorectal cancer. Sulindac helps cells get rid of excess polyamines. Previous studies have shown that these drugs may reduce the chances of colon polyps or the development of a second colon cancer.
HOW LONG WILL PARTICIPANTS BE IN THE STUDY?
Participants will be in the study for eight years. They will take assigned study drugs for three years, after which a member of our research team will follow-up with them every 12 months until the eighth year.
For more information about this trial, contact Mickie Seletyn RN, Research Nurse at Western Maryland Health System, at 240-964-1422. You can also learn more about the trial at swog.org/patients/paces.