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Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
This study is ongoing, but not recruiting participants.
First Received: April 6, 2000   Last Updated: July 16, 2009   History of Changes
Sponsor: Dana-Farber/Brigham and Women's Cancer Center
Collaborator: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00005094
  Purpose

RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. The use of celecoxib has been approved for use in reducing the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP). It is not known whether there is a clinical benefit from a reduction in the number of colorectal polyps in FAP patients. The use of celecoxib may be an effective way to prevent the development of sporadic adenomatous polyps, precursors of colorectal cancer.

PURPOSE: This randomized phase III trial is studying celecoxib to see how well it works compared to a placebo in preventing the development of adenomatous colorectal polyps in patients who have had at least one polyp removed.


Condition Intervention Phase
Colorectal Cancer
Drug: celecoxib
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized
Official Title: Prevention of Sporadic Colorectal Adenomas With Celecoxib (APC)

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: March 2000
Detailed Description:

OBJECTIVES: I. Determine the safety and efficacy of celecoxib in reducing the occurrence of new sporadic adenomatous polyps (SAP) in the colon and rectum in patients who have undergone polypectomy for previous SAP.

OUTLINE: This is a randomized, double blind, placebo controlled study. Patients are entered on one of two treatment arms: Arm I: Patients receive celecoxib twice a day for 3 years. Arm II: Patients receive placebo twice a day for 3 years. Patients are evaluated for adenomatous colorectal polyps at 1 and 3 years.

PROJECTED ACCRUAL: Over 1000 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   30 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS: At least one prior colorectal adenomatous polyp removed by polypectomy within the past 5 months and meeting any of the following criteria: One adenomatous polyp at least 6 cm in size Two or more adenomatous polyps of any size One adenomatous polyp and a documented history of adenomatous polyps No history of familial polyposis or hereditary nonpolyposis colorectal cancer No history of inflammatory bowel disease

PATIENT CHARACTERISTICS: Age: 30 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: No chronic or acute hepatic disorder Renal: No chronic or acute renal disorder Other: No prior participation in this study No significant bleeding disorder or other condition that would preclude study therapy No history of hypersensitivity to COX-2 inhibitors, NSAIDS, salicylates, or sulfonamides No prior invasive cancer within the past 5 years other than nonmelanomatous skin cancer Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: At least 2 months since prior oral corticosteroids received 3 or more times per week At least 6 months since prior oral or intravenous corticosteroids received for more than 2 weeks duration No anticipated oral or intravenous corticosteroid use of more than 2 weeks duration over the next 6 months At least 6 months since prior inhaled corticosteroids received for more than 4 weeks duration No anticipated inhaled corticosteroid use of more than 4 weeks duration over the next 6 months Use of mometasone (Nasonex) is not restricted (all other nasal steroids are prohibited) Radiotherapy: Not specified Surgery: No prior large bowel resection other than appendectomy Other: At least 1 month since any prior treatment for gastrointestinal ulcer At least 2 months since prior nonsteroidal anti-inflammatory drugs (NSAIDS), other than aspirin, received 3 or more times per week No concurrent chronic NSAIDS, defined as a frequency of 1-week (7 consecutive days) for more than 3 weeks per year At least 1 month since prior investigational medications No other concurrent investigational drugs No concurrent fluconazole or lithium

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00005094

  Hide Study Locations
Locations
United States, Alabama
Medical Affiliated Research Center
Huntsville, Alabama, United States, 35801
University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham, Alabama, United States, 35294-3300
United States, Arizona
Urological Associates of Southern Arizona, P.C.
Tucson, Arizona, United States, 85712
United States, California
Advanced Clinical Research Institute
Anaheim, California, United States, 92801
California Professional Research
Newport Beach, California, United States, 92660
Capitol Gastroenterology Consultants Medical Group Inc.
Carmichael, California, United States, 95608
Gastroenterology Associates of the East Bay Medical Center
Berkeley, California, United States, 94705
Institute for Health Care Assessment
San Diego, California, United States, 92120
Saddleback Memorial Medical Center
Laguna Hills, California, United States, 92653
Western Clinic Research, Inc.
Torrance, California, United States, 90505
United States, Colorado
Gastroenterology Associates of Colorado Springs
Colorado Springs, Colorado, United States, 80907
United States, Connecticut
Gastroenterology Associates of Fairfield County
Bridgeport, Connecticut, United States, 06606
United States, Florida
Jupiter Research Association
Jupiter, Florida, United States, 33458
Office of Howard Schwartz
Miami, Florida, United States, 33173
Office of Ira W. Klimberg
Ocala, Florida, United States, 32674
United States, Georgia
Southeastern Digestive and Liver Disease Institute
Savannah, Georgia, United States, 31404
United States, Idaho
Office of Mark Lloyd
Meridian, Idaho, United States, 83642
United States, Illinois
University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Glenbrook Hospital
Glenview, Illinois, United States, 60025
North Shore Endoscopy Center
Lake Bluff, Illinois, United States, 60044
Northwest Gastroenterologists
Arlington Heights, Illinois, United States, 60005
University of Chicago Cancer Research Center
Chicago, Illinois, United States, 60637-1470
Deerpath Medical Associates
Lake Forest, Illinois, United States, 60045
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, United States, 60141
United States, Kansas
Sun Flower Medical Center
Shawnee Mission, Kansas, United States, 66204
United States, Maryland
Health Trends Research, LLC
Baltimore, Maryland, United States, 21208
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States, 21231-2410
United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States, 02114
United States, Minnesota
Mayo Clinic Cancer Center
Rochester, Minnesota, United States, 55905
University of Minnesota Cancer Center
Minneapolis, Minnesota, United States, 55455
United States, Mississippi
Mississippi Center for Clinical Research
Jackson, Mississippi, United States, 39216
United States, New Jersey
New Jersey Physicians, LLC
Passaic, New Jersey, United States, 07055
United States, New York
Herbert Irving Comprehensive Cancer Center
New York, New York, United States, 10032
Long Island GI Research Group
Great Neck, New York, United States, 11023
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Strang Cancer Prevention Center
New York, New York, United States, 10021
Weill Medical College of Cornell University
New York, New York, United States, 10021
United States, North Carolina
Asheville Gastroenterology Associates
Asheville, North Carolina, United States, 28801
C.A.R.E. Center
Raleigh, North Carolina, United States, 27609
Carolinas Medical Center
Charlotte, North Carolina, United States, 28232-2861
Charlotte Gastroenterology and Hepatology
Charlotte, North Carolina, United States, 28207
Comprehensive Cancer Center at Wake Forest University
Winston-Salem, North Carolina, United States, 27157-1082
Moses Cone Health System
Greensboro, North Carolina, United States, 27401-1020
Wake Research Associates, Incorporated
Raleigh, North Carolina, United States, 27612
United States, Ohio
Gastroenterology Associates of Cleveland, Inc.
Mayfield Heights, Ohio, United States, 44140
TQM Research
Cincinnati, Ohio, United States, 45140
United States, Oklahoma
Oklahoma Foundation/Digestive Research
Oklahoma City, Oklahoma, United States, 73104
United States, Oregon
Northwest GI Clinic
Portland, Oregon, United States, 97210
Paul Schleinitz MD and Associates
Medford, Oregon, United States, 97504
United States, Pennsylvania
Allegheny Center for Digestive Health
Pittsburgh, Pennsylvania, United States, 15212
Keystone Digestive Disorders Consultants
Pittsburgh, Pennsylvania, United States, 15224
Regional Gastroenterology Associates of Lancaster
Lancaster, Pennsylvania, United States, 17604
University of Pittsburg Medical Center - Shadyside Hospital
Pittsburgh, Pennsylvania, United States, 15213-2582
Valley Gastroenterology
Beaver Falls, Pennsylvania, United States, 15010
United States, Rhode Island
MultiMed Research
Providence, Rhode Island, United States, 02906
United States, Tennessee
Medical Research Associates of Nashville
Nashville, Tennessee, United States, 37203
Saint Thomas Hospital
Nashville, Tennessee, United States, 37205
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232-6838
United States, Texas
GANT Research, PA
Fort Worth, Texas, United States, 76102
Healthcare Discoveries, P.A.
San Antonio, Texas, United States, 78229
United States, Washington
Northwest Gastroenterology Associates
Bellevue, Washington, United States, 98004
Olympia Multi-Specialty Clinic
Olympia, Washington, United States, 98502
Spokane Digestive Disease Center
Spokane, Washington, United States, 99204
United States, Wisconsin
Wisconsin Center for Advanced Research
Milwaukee, Wisconsin, United States, 53207
United States, Wyoming
Veterans Affairs Medical Center - Sheridan
Sheridan, Wyoming, United States, 82801
Australia
Fremantle Hospital
Fremantle, Australia, 6160
Australia, New South Wales
Concord Repatriation General Hospital
Concord, New South Wales, Australia, 2139
Sydney Children's Hospital
Randwick, New South Wales, Australia, 2031
Australia, Queensland
Royal Brisbane Hospital
Brisbane, Queensland, Australia, 4029
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Monash Medical Center
Clayton, Victoria, Australia, 3168
Royal Melbourne Hospital
Parkville, Victoria, Australia, 3050
Western Hospital
Melbourne, Victoria, Australia, 3011
Australia, Western Australia
Sir Charles Gairdner Hospital, Perth
Perth, Western Australia, Australia, 6009
Canada
Hamilton Civic Hospital Research Centre
Hamilton, Canada, L8V-IC3
Canada, Alberta
Health Sciences Centre
Calgary, Alberta, Canada, T2N 4N1
Hys. Medical Ctre.
Edmonton, Alberta, Canada, T5H 4B9
Canada, British Columbia
Vancouver Hospital and Health Sciences Center - BCCA
Vancouver, British Columbia, Canada, V5Z 1L5
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R9
Canada, Nova Scotia
Queen Elizabeth II Health Science Center
Halifax, Nova Scotia, Canada, B3H 2Y9
Canada, Ontario
Ottawa Hospital
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Sciences Center
Toronto, Ontario, Canada, M4X 1W4
Canada, Quebec
Centre Hospital University
Quebec City, Quebec, Canada, G1L 3L5
Centre Hospitalier de l'Universite' de Montreal
Montreal, Quebec, Canada, H2W 1T8
Centre Hospitalier Universitaire de Quebec
Quebec City, Quebec, Canada, G1R 2J6
Hospital Maisooneuve Rosemont
Montreal, Quebec, Canada, H1T 2M4
Jewish General Hospital - Montreal
Montreal, Quebec, Canada, H3T 1E2
Montreal General Hospital
Montreal, Quebec, Canada, H3G 1A4
Royal Victoria Hospital - Montreal
Montreal, Quebec, Canada, H3A 1A1
Canada, Saskatchewan
St. Paul's Hospital
Saskatoon, Saskatchewan, Canada, S7K 1N4
United Kingdom, England
South Tees Hospitals NHS Trust
Middlesbrough, Cleveland, England, United Kingdom, TS4 3BW
Sponsors and Collaborators
Dana-Farber/Brigham and Women's Cancer Center
Investigators
Study Chair: Monica M. Bertagnolli, MD Dana-Farber/Brigham and Women's Cancer Center
  More Information

Additional Information:
Publications:
Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Breazna A, Kim K, Tang J, Rosenstein RB, Umar A, Bagheri D, Collins NT, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Hawk ET; Adenoma Prevention with Celecoxib Study Investigators. Five-year efficacy and safety analysis of the Adenoma Prevention with Celecoxib Trial. Cancer Prev Res (Phila Pa). 2009 Apr;2(4):310-21. Epub 2009 Mar 31.
Cho NL, Redston M, Zauber AG, Carothers AM, Hornick J, Wilton A, Sontag S, Nishioka N, Giardiello FM, Saltzman JR, Gostout C, Eagle CJ, Hawk ET, Bertagnolli MM. Aberrant crypt foci in the adenoma prevention with celecoxib trial. Cancer Prev Res (Phila Pa). 2008 Jun;1(1):21-31. Epub 2008 Apr 14.
Bertagnoli MM, Eagle CJ, Hawk ET: Celecoxib reduces sporadic colorectal adenomas: results from the Adenoma Prevention with Celecoxib (APC) trial. [Abstract] American Association for Cancer Research: 97th Annual Meeting, April 1-5, 2006, Washington, DC. A-CP-3, 2006.
Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET; APC Study Investigators. Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med. 2006 Aug 31;355(9):873-84.
Solomon SD, Pfeffer MA, McMurray JJ, Fowler R, Finn P, Levin B, Eagle C, Hawk E, Lechuga M, Zauber AG, Bertagnolli MM, Arber N, Wittes J; APC and PreSAP Trial Investigators. Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation. 2006 Sep 5;114(10):1028-35.

Study ID Numbers: CDR0000067750, BWH-NO1-CN-95015, NYH-CMC-0298-108, SC-IQ4-99-02-005, STRANG-98-008, NCI-P00-0141
Study First Received: April 6, 2000
Last Updated: July 16, 2009
ClinicalTrials.gov Identifier: NCT00005094     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
colon cancer
rectal cancer

Additional relevant MeSH terms:
Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Diseases
Colonic Diseases
Physiological Effects of Drugs
Rectal Diseases
Neoplasms by Site
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Celecoxib
Digestive System Neoplasms
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Intestinal Diseases
Intestinal Neoplasms
Pharmacologic Actions
Neoplasms
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on November 27, 2009