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| 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) |
| Study Start Date: | March 2000 |
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 |
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
Hide Study 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 | |
| Study Chair: | Monica M. Bertagnolli, MD | Dana-Farber/Brigham and Women's Cancer Center |
More Information
| 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 |
|
colon cancer rectal cancer |
|
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 |