New York, NY, February 19, 2002 -- Columbia Presbyterian Medical Center of NewYork- Presbyterian Hospital is seeking participants for an investigation of the potential tumor-fighting capabilities of the drug Celebrex™.  The National Cancer Institute-sponsored trial studies the role of Celebrex™ in preventing the development of colon polyps, benign growths in the lining of the colon that often precede colon cancer.  Columbia Presbyterian Medical Center is one of two New York metropolitan area hospitals participating in the multi-center study, which has been ongoing since October 1999, along with leading researchers at 100 other sites in United States, the United Kingdom, and Canada.
            The efficacy of the drug Celebrex™ has been attributed to the suppression of a key enzyme (cyclooxygenase-2, or COX-2) that is linked to the formation of both colon polyps and colon cancer.  The study will determine whether suppressing the COX-2 enzyme will lead to a reduction in the overall occurrences of adenomatous polyps, the second most common form of colon polyp.  Based on a National Cancer Institute trial, Celebrex™ was approved by the Food and Drug Administration (FDA) as an adjunct to usual care – which entails removal of polyps either surgically or during a colonoscopy – for patients with familial adenomatous polyposis (FAP), a hereditary disease which is marked by the chronic growth of colon polyps and eventual development of colorectal cancer if left untreated.
            The COX-2 inhibitor Celebrex™ has also been shown to exhibit minor to zero side-effects when taken daily.  Other non-steroidal anti-inflammatory drugs, such as Aspirin and Motrin, also suppress COX-2 but with adverse side effects such as gastrointestinal bleeding, abdominal discomfort, and ulcers.  Study results published in the Sept 13, 2000, issue of the Journal of the
American Medical Association (JAMA) show that patients who took Celebrex™ were two to three times less likely to experience gastrointestinal complications than those who received ibuprofen or diclofenac, another anti-arthritic anti-inflammatory drug.
            “This study has tremendous potential to show that we have a very safe drug that could prevent colon cancer in a large population,” said Dr. Charles J. Lightdale, attending physician in the Department of Medicine at Columbia Presbyterian Medical Center of NewYork-Presbyterian Hospital, professor of clinical medicine at Columbia University College of Physicians & Surgeons, and principal investigator at this site.  “People should know that once they have colon polyps they are at increased risk of having colon cancer.  This affects men and women equally.”
            Colon cancer is the second most common form of cancer in the United States and the number three cause of cancer death in Americans.  The appearance of an adenomatous polyp precedes malignant tumors in 95% percent of all colon cancer cases.  Close to 50% of people ages 60 and older will have at least one adenomatous polyp in the lining of the colon.
            To qualify for the study, candidates must be 30 years of age and older and are required to have a history of colon polyps or a family history of colon polyps or colon cancer.  The individuals who meet the study criteria will be placed in a randomized trial in which two out of three patients will receive the drug Celebrex™ in two different daily dosages (400 and 800 milligrams), and one out of three patients will receive a placebo.  The study will take place over a three-year period, in which the patient will visit the doctor once every three months for the first year, and once every six months for the remaining two years.  The patient will also receive an endoscopy after one year and after the three-year anniversary at no cost to them.
            The National Cancer Institute's Division of Cancer Prevention is studying Celebrex™ for the prevention of cancer in people with precancerous conditions and in people at high risk for recurring cancer.  NCI is collaborating with Pharmacia Corporation of Peapack, New Jersey, the makers of Celebrex™, and Pfizer Incorporated in New York, New York.  To date there are 1,549 subjects randomized.
            Prospective study participants should contact the Columbia Presbyterian Medical Center directly at 212.305.3224.