UPCI Physicians Begin Polyp Prevention Study For People At Risk For Colorectal Cancer

Apr 02, 2001, 01:00 ET from UPMC Health System

    PITTSBURGH, April 2 /PRNewswire/ -- Researchers at the University of
 Pittsburgh Cancer Institute (UPCI) are participating in an international
 multi-center trial to determine if Vioxx(R), a drug approved for pain relief
 and arthritis, can safely and effectively prevent the recurrence of
 precancerous growths in the colon. There is currently no treatment to prevent
 the recurrence of these growths, called adenomatous polyps, which are the
 precursors to colon cancer.
     Next to lung cancer, colorectal cancer is the second leading cause of
 cancer-related deaths in the United States. It affects both men and women to a
 significant degree. Each year, colorectal cancer is diagnosed in more than
 140,000 patients in the United States with an annual mortality of 56,000
 individuals.
     Prevention of colorectal cancer is currently focused on identifying
 individuals with precursor growths and removing them during colonoscopy, a
 procedure where a scope is put into the large bowel to inspect the lining for
 cancer and pre-cancerous changes, thereby preventing subsequent development of
 cancer. Patients who develop polyps are more likely to get them again and need
 to undergo routine surveillance.
     "Since adenomatous polyps play a significant role in the progression to
 colorectal cancer, it is critical to eliminate them in the early stages before
 cancer develops, or to prevent them from forming," said Robert E. Schoen,
 M.D., M.P.H., associate professor of medicine and epidemiology, director of
 the Colorectal and G.I. Cancer Prevention and Control Research at UPCI and
 principal investigator of the study.
     Vioxx, which is manufactured by Merck & Co., Inc., has been approved by
 the U.S. Food and Drug Administration for the treatment of symptoms related to
 osteoarthritis, the management of acute pain and the treatment of menstrual
 cramps. Recent studies suggest that drugs like Vioxx may be effective in
 preventing the recurrence of colon polyps as well.
     About 60 participants at the University of Pittsburgh will take part in
 the study, which is a three-year, randomized trial. Participating centers in
 the Pittsburgh study include, UPMC Presbyterian, UPMC South Side, UPMC St.
 Margaret, UPMC Passavant, UPMC Shadyside and Three Rivers Endoscopy Center in
 Moon Township. More than 2,400 patients will be enrolled at 70 sites in the
 U.S., Canada and Europe.
     Study participants must be at least 40 years old and have had an
 endoscopic colon examination with removal of an adenomatous polyp within the
 previous 12 weeks prior to entry in the study.  Following a six-week run-in
 period, 60 patients will be randomized to treatment with either 25mg of Vioxx
 or a placebo. Colonoscopy will be performed after the first year and after the
 third year to look for evidence of recurrence of colorectal adenomas.
 Participants will be closely monitored for any adverse effects throughout the
 study through clinic visits, phone contacts, and self-monitoring.
     Despite improvements of surgical technique and the development of adjuvant
 chemotherapy, cure rates for advanced colorectal disease have remained low.
 Endoscopic removal of polyps is the standard of care.  Research has focused on
 developing a safe chemopreventive treatment that will effectively reduce
 recurrent polyp growths.  "Ultimately, this research could lead to a therapy
 which would prevent colorectal cancer from developing," said Dr. Schoen.
     For more information about the polyp prevention trial, please call
 412-648-9116.
 
     CONTACT: Maureen McGaffin, mcgaffinme@msx.upmc.edu, or Jocelyn Uhl,
 uhljh@msx.upmc.edu, both of UPMC, 412-647-3555, or fax, 412-624-3184.
 
 

SOURCE UPMC Health System
    PITTSBURGH, April 2 /PRNewswire/ -- Researchers at the University of
 Pittsburgh Cancer Institute (UPCI) are participating in an international
 multi-center trial to determine if Vioxx(R), a drug approved for pain relief
 and arthritis, can safely and effectively prevent the recurrence of
 precancerous growths in the colon. There is currently no treatment to prevent
 the recurrence of these growths, called adenomatous polyps, which are the
 precursors to colon cancer.
     Next to lung cancer, colorectal cancer is the second leading cause of
 cancer-related deaths in the United States. It affects both men and women to a
 significant degree. Each year, colorectal cancer is diagnosed in more than
 140,000 patients in the United States with an annual mortality of 56,000
 individuals.
     Prevention of colorectal cancer is currently focused on identifying
 individuals with precursor growths and removing them during colonoscopy, a
 procedure where a scope is put into the large bowel to inspect the lining for
 cancer and pre-cancerous changes, thereby preventing subsequent development of
 cancer. Patients who develop polyps are more likely to get them again and need
 to undergo routine surveillance.
     "Since adenomatous polyps play a significant role in the progression to
 colorectal cancer, it is critical to eliminate them in the early stages before
 cancer develops, or to prevent them from forming," said Robert E. Schoen,
 M.D., M.P.H., associate professor of medicine and epidemiology, director of
 the Colorectal and G.I. Cancer Prevention and Control Research at UPCI and
 principal investigator of the study.
     Vioxx, which is manufactured by Merck & Co., Inc., has been approved by
 the U.S. Food and Drug Administration for the treatment of symptoms related to
 osteoarthritis, the management of acute pain and the treatment of menstrual
 cramps. Recent studies suggest that drugs like Vioxx may be effective in
 preventing the recurrence of colon polyps as well.
     About 60 participants at the University of Pittsburgh will take part in
 the study, which is a three-year, randomized trial. Participating centers in
 the Pittsburgh study include, UPMC Presbyterian, UPMC South Side, UPMC St.
 Margaret, UPMC Passavant, UPMC Shadyside and Three Rivers Endoscopy Center in
 Moon Township. More than 2,400 patients will be enrolled at 70 sites in the
 U.S., Canada and Europe.
     Study participants must be at least 40 years old and have had an
 endoscopic colon examination with removal of an adenomatous polyp within the
 previous 12 weeks prior to entry in the study.  Following a six-week run-in
 period, 60 patients will be randomized to treatment with either 25mg of Vioxx
 or a placebo. Colonoscopy will be performed after the first year and after the
 third year to look for evidence of recurrence of colorectal adenomas.
 Participants will be closely monitored for any adverse effects throughout the
 study through clinic visits, phone contacts, and self-monitoring.
     Despite improvements of surgical technique and the development of adjuvant
 chemotherapy, cure rates for advanced colorectal disease have remained low.
 Endoscopic removal of polyps is the standard of care.  Research has focused on
 developing a safe chemopreventive treatment that will effectively reduce
 recurrent polyp growths.  "Ultimately, this research could lead to a therapy
 which would prevent colorectal cancer from developing," said Dr. Schoen.
     For more information about the polyp prevention trial, please call
 412-648-9116.
 
     CONTACT: Maureen McGaffin, mcgaffinme@msx.upmc.edu, or Jocelyn Uhl,
 uhljh@msx.upmc.edu, both of UPMC, 412-647-3555, or fax, 412-624-3184.
 
 SOURCE  UPMC Health System