Celecoxib to Prevent Colorectal Cancer in Patients Who Have Undergone Surgery to Remove Polyps
|Phase III||Prevention||Closed||30 and over||NCI||BWH-NO1-CN-95015|
NYH-CMC-0298-108, SC-IQ4-99-02-005, STRANG-98-008, NCI-P00-0141, NCT00005094
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.
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
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
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
Over 1000 patients will be accrued for this study.
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.Published Results
Chan AT, Hsu M, Zauber AG, et al.: The influence of UGT1A6 variants and aspirin use in a randomized trial of celecoxib for prevention of colorectal adenoma. Cancer Prev Res (Phila) 5 (1): 61-72, 2012.[PUBMED Abstract]
Bertagnolli MM, Hsu M, Hawk ET, et al.: Statin use and colorectal adenoma risk: results from the adenoma prevention with celecoxib trial. Cancer Prev Res (Phila Pa) 3 (5): 588-96, 2010.[PUBMED Abstract]
Bertagnolli MM, Eagle CJ, Zauber AG, et al.: Five-year efficacy and safety analysis of the Adenoma Prevention with Celecoxib Trial. Cancer Prev Res (Phila Pa) 2 (4): 310-21, 2009.[PUBMED Abstract]
Cho NL, Redston M, Zauber AG, et al.: Aberrant crypt foci in the adenoma prevention with celecoxib trial. Cancer Prev Res (Phila Pa) 1 (1): 21-31, 2008.[PUBMED Abstract]
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, et al.: Celecoxib for the prevention of sporadic colorectal adenomas. N Engl J Med 355 (9): 873-84, 2006.[PUBMED Abstract]Related Publications
Arber N, Lieberman D, Wang TC, et al.: The APC and PreSAP trials: a post hoc noninferiority analysis using a comprehensive new measure for gastrointestinal tract injury in 2 randomized, double-blind studies comparing celecoxib and placebo. Clin Ther 34 (3): 569-79, 2012.[PUBMED Abstract]
Solomon SD, Pfeffer MA, McMurray JJ, et al.: Effect of celecoxib on cardiovascular events and blood pressure in two trials for the prevention of colorectal adenomas. Circulation 114 (10): 1028-35, 2006.[PUBMED Abstract]
Trial Lead Organizations
Dana-Farber/Brigham and Women's Cancer Center
|Monica Bertagnolli, MD, Protocol chair|
|Official Title||Prevention of Sporadic Colorectal Adenomas with Celecoxib (APC)|
|Trial Start Date||2000-03-07|
|Registered in ClinicalTrials.gov||NCT00005094|
|Date Submitted to PDQ||2000-03-07|
|Information Last Verified||2012-07-23|
Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.