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NIH Halts Use of COX-2 Inhibitor in Large Cancer Prevention Trial
On December 17, the National Institutes of Health (NIH) announced that it suspended the use of the COX-2 inhibitor celecoxib (Celebrex) for all participants in a large colorectal cancer prevention clinical trial conducted by the National Cancer Institute (NCI). The study - the Adenoma Prevention with Celecoxib (APC) trial - was stopped because analysis by an independent Data Safety and Monitoring Board showed a 2.5-fold increased risk of major fatal and nonfatal cardiovascular events for participants taking the drug compared with those on a placebo.
Additional cardiovascular expertise was added to the safety monitoring committee at the request of the steering committee for this trial after a September 2004 report that the COX-2 inhibitor rofecoxib (Vioxx) caused a two-fold increased risk of cardiovascular toxicities in a trial to prevent adenomas. The APC trial is a study of more than 2,000 people who have had a precancerous growth (adenomatous polyp) removed. They were randomized to take either 200 mg of celecoxib twice a day, 400 mg of celecoxib twice a day, or a placebo for 3 years. The trial began in early 2000 and is scheduled to be completed by spring 2005.
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NCI Leadership: Building Upward, Moving Forward
When I arrived here in January 2002, I was privileged to join an organization with a long and distinguished history of achievement and a reputation for innovative leadership. What I have experienced during my first 3 years as Director has only increased my deep respect for all of the talented and dedicated staff at NCI and in the broader cancer community who are committed to the challenge of eliminating the suffering and death due to cancer. Each of us contributes in our own way to achieving this goal, and all of our efforts are necessary to ensure success.
In the coming year, we will face a number of critical challenges and opportunities; the decisions we make in 2005 could affect cancer research for decades to come. Perhaps more than ever before, innovative and dynamic leadership will prove to be the difference. That's why I've implemented steps that will ensure the NCI leadership structure is best positioned to meet every success and exploit every opportunity. Over the next two issues of the NCI Cancer Bulletin, I will provide you with a glimpse of how the NCI Office of the Director will evolve to more effectively meet future challenges.
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The NCI Cancer Bulletin is produced by the National Cancer Institute (NCI). NCI, which was established in 1937, leads the national effort to eliminate the suffering and death due to cancer. Through basic, clinical, and population-based biomedical research and training, NCI conducts and supports research that will lead to a future in which we can identify the environmental and genetic causes of cancer, prevent cancer before it starts, identify cancers that do develop at the earliest stage, eliminate cancers through innovative treatment interventions, and biologically control those cancers that we cannot eliminate so they become manageable, chronic diseases.
For more information on cancer, call 1-800-4-CANCER or visit http://www.cancer.gov.
NCI Cancer Bulletin staff can be reached at ncicancerbulletin@mail.nih.gov.
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