This is a randomized, double-blind placebo-controlled pharmacologic intervention trial in HNPCC patients and carriers (with or without prior clinical manifestations). The study arms are: 1) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #1 p.o. BID, 2) cyclooxygenase-2 (COX-2) inhibitor or NSAID at dose #2 p.o. BID, and 3) placebo. There will be 18 patients randomized to each of the arms. The study drugs will be given for twelve months (365+/- 10 days). Assessment of endoscopic, histopathologic, and cellular endpoints will be conducted at baseline, three, and twelve months on study drug or placebo. Safety monitoring will occur via in- patient interviews with exams at months three and twelve; blood and UA's at months one, three, six, nine, and twelve; and via telephone interviews at monthly (at weeks two and four of month one) intervals. A post- administration telephone call to evaluate side effect resolution will occur at month 14, in those with side effects at termination. A parallel project involving approximately 20 subjects will be conducted at another NCI-designated site; NCI will coordinate the efforts and activities of both sites.

Agency
National Institute of Health (NIH)
Institute
Division of Cancer Prevention And Control (NCI)
Type
Research and Development Contracts (N01)
Project #
N01CN075021-001
Application #
2879697
Study Section
Project Start
1997-04-30
Project End
Budget Start
1998-09-30
Budget End
1999-07-31
Support Year
Fiscal Year
1998
Total Cost
Indirect Cost
Name
University of Texas MD Anderson Cancer Center
Department
Type
DUNS #
001910777
City
Houston
State
TX
Country
United States
Zip Code
77030