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Giants

New Phase III Trial

Lisa Schulmeister, RN, MN, APRN-BC, OCN, FAAN
Published Online: Monday, August 19, 2013
Colorectal cancer is recognized as a common cancer and is the third leading cause of cancer mortality. As with many other types of cancer, people who have been treated for colon cancer are at increased risk for developing a new colon cancer. To explore if colorectal cancer recurrence can be reduced after initial treatment, the National Cancer Institute, Southwest Oncology Group, and Cancer Prevention Pharmaceuticals, Inc., recently announced a phase III trial called the Preventing Adenomas of the Colon with Eflornithine and Sulinidac (PACES) trial.The primary objective is to assess whether eflornithine 500 mg or sulindac 150 mg (or both) are effective in reducing the 3-year event rate, defined as high risk adenoma or 2nd primary colorectal cancer, in patients with Stage 0, I, II, and III colon cancer. Both drugs work to lower levels of polyamines, which are naturally-formed molecules that play a role in the development of colorectal cancer. Eflornithine slows the body's production of polyamines and sulindac helps cells eliminate excess polyamines.

The researchers chose these two drugs because of an earlier study that looked at their preventive effects in patients who already had at least one adenoma removed from their colon. In that study, participants who took the 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. They lowered their chances of developing high-risk adenomas or multiple adenomas during that time by 90%. Information about the trial and patient enrollment criteria are available at http://clinicaltrials.gov/ct2/show/NCT01349881.
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