DFMO & SULINDAC TO DECREASE RATE OF RECURRENCE OF ADENOMATOUS POLYPS IN COLON

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This research study is investigating cancer of the large bowel (colon and rectum) by studying persons with colon or rectal polyps (abnormal tissue growth). People with this condition are at increased risk for subsequent polyps and large bowel cancer. The usual treatment for polyps is to remove them when possible or carefully follow them with colonoscopy (a procedure used to look at the inside of the bowel, rectum and colon) and biopsy (taking samples of tissue.) Biopsies are done to make sure that there are no changes in the tissue suggesting the development of cancer. The development of large bowel cancer has been related to the presence of certain chemical substances (polyamines, prostaglandins) in the lining of the bowel. The purpose of this study is to determine whether DFMO 500mg (250mg x 2)/day plus Sulindac 150mg/day taken by mouth every day, will decrease the development of polyps when given over 36 months. The levels of polyamines and prostaglandins will also be measured. Another purpose for this study is to determine if side effects develop as the result of these drugs at these doses. Participants in this study will be asked to take either the combination of DFMO plus Sulindac or a placebo (inactive agent) orally each day for a total of 3 years. You will be assigned to a treatment using a process called randomization, which is similar to flipping a coin. Although topical DFMO is an approved drug for a specialized indication, DFMO is regarded an investigational drug (not approved by the United States Food and Drug Administration for general use by physicians). Sulindac is approved for certain purposes but has not been approved for my condition and is therefore considered investigational. Over the Network of accrual sites across the United States, approximately 500 patients will be entered into the study.