Thank you for your interest in the PACES (S0820) colon cancer chemoprevention study.
This phase III clinical trial will enroll about 1,488 volunteers who have recently been treated for colon cancer. The goal is to learn whether by taking the drugs eflornithine
and sulindac, these participants can lower their risk of developing new
adenomas (precancerous polyps) or a second primary cancer in their colon.
This information page does not replace the study's detailed informed
consent form or information from your study doctor. The PACES trial is SWOG S0820, National Cancer Institute NCT01349881 (protocol rev 11/15/12).
What is a clinical trial?
A phase III clinical trial is one of the final stages of a long and careful cancer research process. Studies are done with cancer patients and other volunteers to find out whether promising approaches to cancer prevention, diagnosis, and treatment are safe and effective, and to answer questions that will improve cancer care. Most of the cancer treatments that extend lives today are the product of extensive clinical trials with hundreds or thousands of past volunteers.
What question is this trial hoping to answer?
The PACES trial asks whether someone who has been treated for colon cancer in the past can lower their risk of having a second primary colorectal cancer or an adenoma (a type of polyp on the colon wall that may be precancerous) by regularly taking one or both of the study drugs.
Can I take part?
You may be eligible to take part in PACES if you have had stage 0, I, II, or III colon cancer and
- you've had surgery for that colon cancer within the past 9 - 15 months,
- you've completed any chemotherapy you may have had, and
- you 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 will I be asked to do if I take part?
If you are eligible and decide to volunteer for the PACES trial:
- You will first have a series of tests, including a colonoscopy and a hearing exam.
- You will receive a supply of two types of pills, which you will take every day for the next three years. You will also get a calendar to record when you take the pills.
- During your first year on the trial you will visit your study doctor every three months for a physical exam and lab tests.
- During your second and third years on the trial, you will visit your study doctor every six months for a physical exam and lab tests. You may also have other tests done such as a CT scan or a colonoscopy if your doctor thinks it necessary.
- At the end of the three years, you will have another hearing exam and colonoscopy.
- From year four to year seven, you will have an annual physical exam.
- Eight years after you first enroll in the trial you will have a follow-up colonoscopy as part of routine monitoring.
You can leave the trial at any time, if you choose to.
How does this differ from the care I'll get if I don't take part in the PACES trial?
If you don't take part in this study, your follow-up care and monitoring visits with your doctor will probably follow a similar schedule, though you will not take the daily pills you would take for the trial and you will not have the hearing exams.
My colon cancer is gone. Why should I risk taking more drugs?
If you have already had colon cancer once, you are at higher risk of having another cancer. In one recent large study of people who had had successful colon cancer surgery, about one out of three, or one-third of the group, developed at least one new adenoma in their colon within three years following their surgery. Most colon cancers start out as adenomas.
What drugs are used in the trial?
The drugs used are eflornithine and sulindac. Eflornithine in pill form is an investigational drug not otherwise available, though eflornithine has been used intravenously to treat trypanosomiasis (sleeping sickness) and in a skin cream to reduce unwanted hair growth. Sulindac is not approved yet for this use by the U.S. Food and Drug Administration (FDA), but it is approved for use as a nonsteroidal anti-inflammatory pain reliever and is sometimes used to treat arthritis pain.
Why were these drugs chosen?
An earlier study looked at the preventive effects of these drugs in people who had already had at least one adenoma removed from their colon. Those who took this drug combination lowered their risk of developing another adenoma over the next three years to less than one third of what it was for those who did not take the drugs. And they lowered their chances of developing a high-risk adenoma during that time by 90%.
The PACES trial hopes to learn whether these drugs can also lower the risk of adenomas or new colorectal cancers among patients who have had colon cancer tumors removed in the past.
Why are both drugs being tested together?
Both drugs work to lower your body's levels of a group of naturally-formed molecules called polyamines, but each drug works in a different way. Excess polyamines have a role in the development of colorectal cancer. Eflornithine slows your body's production of polyamines. Sulindac helps cells get rid of excess polyamines.
What are some possible side effects of these drugs?
| Avoiding drug interactions
You should not take blood thinners (such as coumadin or heparin) or corticosteroids while on this trial.
You should limit your use of nonsteroidal anti-inflammatory drugs (such as the pain medicine ibuprofen) to no more than 10 times per month while on this study.
You should also limit your use of aspirin to no more than 100 mg per day or no more than two standard adult dose (325 mg) tablets per week.
Nausea, vomiting, diarrhea, stomach pain, headache, dizziness, constipation, and rash have been reported by some patients taking eflornithine. Taking your pills with food will reduce your chance of stomach upset.
High doses of eflornithine (up to 30 times the dose used in PACES) have been associated with hearing loss. In earlier trials of eflornithine at doses similar to the PACES dose, audiogram testing revealed mild hearing loss for a small number of patients who had taken the drug, although patients themselves did not report any changes in their hearing. Your doctor will monitor you throughout the study for any signs of hearing loss.
An earlier trial of eflornithine and sulindac found a slight increase in the number of cardiovascular problems among those who had entered the study already in a high cardiovascular risk category. The trial found no increased risk of such problems for volunteers who had started the study with a low or moderate cardiovascular risk level. For this reason, those with a high cardiovascular risk profile are not eligible to participate in the PACES trial.
The chance that you will experience serious side effects from these drugs is low. Your study doctor and research team will review the full list of possible side effects with you as part of the informed consent process.
Will everyone on the trial get the same drugs?
No. To learn whether the study drugs reduce colon cancer risk, researchers must compare a group of volunteers taking the drugs to a similar group of volunteers who don't take the drugs.
If you join the trial, you will be assigned at random to one of four study groups, or arms. You have a fair and equal chance of being placed into any given study arm.
Participants on all arms will take three pills each day -- 2 lighter-colored pills and 1 golden-yellow pill. One or both of those types of pills may be placebos (pills with no active medication).
Neither you nor your doctor will know whether the pills you take are the two drugs, one drug and one placebo, or two placebos. This "double blinding" helps lower the chance that the expectations of the doctor or the participant will affect the trial results. You will be told at the end of the trial which pills you got.
Will I see any benefits from taking part?
We hope that participants getting the two drugs will have a lower rate of adenomas, but we don't know yet whether this will be the case. We do know that you will be closely monitored for any new adenomas or cancer throughout your time on the trial.
Your taking part will help us learn whether these two drugs can help tens of thousands of colon cancer survivors each year lower their risk of developing new adenomas or cancer. Just as most of the treatments and preventive measures you benefit from today were developed or confirmed in clinical trials with past volunteers, future cancer survivors would see the benefits of your contributions.
How would taking part affect the cost of my care?
Taking part in the PACES trial will probably not significantly affect the cost of your care, but we can't say that for sure.
The pills you take for the trial will be provided at no cost to you. You will also have two hearing tests at no cost to you.
The other tests and scans done during the trial are considered part of standard care and monitoring for colon cancer survivors, and you or your insurance company will be billed (just as if you were not in a clinical trial). Insurance companies and Medicare generally cover the routine costs of care required within a clinical trial, but coverage varies from plan to plan. Check with your provider.
Who is conducting the trial?
The trial is being conducted by SWOG, a nationwide cancer research cooperative group that is supported largely by National Cancer Institute (NCI) funding. Several other NCI-funded cooperative groups are collaborating on the trial as well. The doctor leading the trial is Dr. Jason A. Zell, D.O., M.P.H., of the University of California, Irvine Medical Center.
Where is the trial open?
Click this link and scroll to "Contacts and Locations" for a list of particpating institutions. Or ask your health care provider whether the trial is open at his or her site.
Who can I talk to if I have questions?
If you have questions, please talk to your study doctor or another member of your study team.
This page is a patient's introduction to the PACES S0820 clinical trial. It does not replace the study's detailed informed consent form or information from your study doctor. The content on this page has been reviewed by the Institutional Review Board of the University of Michigan (HUM00071475).
S0820 protocol rev 20121115