| The safety and efficacy of celecoxib in children with familial adenomatous polyposis. | |
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MedLine Citation:
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PMID: 20234350 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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OBJECTIVES: Celecoxib is approved as an adjunctive chemopreventive agent in adults with familial adenomatous polyposis (FAP). Its safety and efficacy for colorectal polyps in children is unknown. We evaluated the short-term (3 months) safety and preliminary efficacy of celecoxib in children with FAP. METHODS: This was a phase I, dose-escalation trial, with three successive cohorts of six children. Children of ages 10-14 years with APC gene mutations and/or adenomas with a family history of FAP were studied at M.D. Anderson Cancer Center and the Cleveland Clinic. Colonoscopy was performed at baseline and month 3. Random assignment was in a 2:1 generic:placebo ratio, escalating from cohort 1 (4 mg/kg/day) to cohort 2 (8 mg/kg/day) to cohort 3 (16 mg/kg/day). Adherence and adverse event (AE) monitoring was conducted at 2-week intervals during drug administration. Safety profile, difference in number, and percent change in colorectal polyps were compared among the four treatments (placebo and the three dose-escalation groups). RESULTS: Eighteen subjects completed drug dosing and both colonoscopies. Median age was 12.3 years (56% female). No clinically meaningful differences in AEs were seen between placebo subjects and subjects at any of the three celecoxib doses. Median polyp count at baseline was 31. There was a 39.1% increase in the number of polyps in placebo subjects at month 3, whereas in the highest dose celecoxib group, 16 mg/kg/day, a 44.2% reduction was seen (P=0.01). CONCLUSIONS: Celecoxib at a dose of 16 mg/kg/day, corresponding to the adult dose of 400 mg BID, is safe, well tolerated, and significantly reduced the number of colorectal polyps in children with FAP. |
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Authors:
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Patrick M Lynch; Gregory D Ayers; Ernie Hawk; Ellen Richmond; Craig Eagle; Mabel Woloj; James Church; Hennie Hasson; Sherri Patterson; Elizabeth Half; Carol A Burke |
Publication Detail:
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Type: Clinical Trial, Phase I; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, N.I.H., Extramural Date: 2010-03-16 |
Journal Detail:
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Title: The American journal of gastroenterology Volume: 105 ISSN: 1572-0241 ISO Abbreviation: Am. J. Gastroenterol. Publication Date: 2010 Jun |
Date Detail:
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Created Date: 2010-06-04 Completed Date: 2010-07-15 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 0421030 Medline TA: Am J Gastroenterol Country: United States |
Other Details:
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Languages: eng Pagination: 1437-43 Citation Subset: IM |
Affiliation:
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Department of Gastroenterology, Hepatology and Nutrition, University of Texas M.D. Anderson Cancer Center, Houston, Texas 77230-1402, USA. plynch@mdanderson.org |
Export Citation:
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| MeSH Terms | |
Descriptor/Qualifier:
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Adenoma
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diagnosis,
prevention & control* Adenomatous Polyposis Coli / diagnosis, drug therapy* Adolescent Child Cohort Studies Colonic Neoplasms / diagnosis, prevention & control* Colonic Polyps / diagnosis, prevention & control* Colonoscopy Cyclooxygenase 2 Inhibitors / therapeutic use* Dose-Response Relationship, Drug Double-Blind Method Female Humans Male Pyrazoles / therapeutic use* Sulfonamides / therapeutic use* Treatment Outcome |
| Grant Support | |
ID/Acronym/Agency:
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N01-CN-05126-02/CN/NCI NIH HHS |
| Chemical | |
Reg. No./Substance:
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0/Cyclooxygenase 2 Inhibitors; 0/Pyrazoles; 0/Sulfonamides; 169590-42-5/celecoxib |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
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