Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2026-02-22 @ 6:36 PM
Study NCT ID:
NCT00685568
Status:
COMPLETED
Last Update Posted:
2018-11-07
First Post:
2008-05-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal Neoplasms'}, {'id': 'D011125', 'term': 'Adenomatous Polyposis Coli'}], 'ancestors': [{'id': 'D007414', 'term': 'Intestinal Neoplasms'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D012002', 'term': 'Rectal Diseases'}, {'id': 'D018256', 'term': 'Adenomatous Polyps'}, {'id': 'D000236', 'term': 'Adenoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009386', 'term': 'Neoplastic Syndromes, Hereditary'}, {'id': 'D044483', 'term': 'Intestinal Polyposis'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 22}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-11-21', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2006-04-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-05', 'studyFirstSubmitDate': '2008-05-23', 'studyFirstSubmitQcDate': '2008-05-23', 'lastUpdatePostDateStruct': {'date': '2018-11-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-05-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Aberrant crypt foci (ACF) and adenoma burden in the entire colorectum', 'timeFrame': '3 months'}, {'measure': 'Elimination of the learning curve in a phase II/III trial', 'timeFrame': '3 months'}, {'measure': 'Comparison of sedation strategies based on local standards', 'timeFrame': '3 months'}, {'measure': 'Validation of technique for scoring ACFs', 'timeFrame': '3 months'}, {'measure': 'Short-term (3 month) impact of celecoxib on ACF count', 'timeFrame': '3 months'}, {'measure': 'Adherence', 'timeFrame': '3 months'}, {'measure': 'Influence of polymorphisms on age of onset of phenotype or on the number of colorectal polyps', 'timeFrame': '3 months'}, {'measure': 'Feasibility of psychosocial questionnaires', 'timeFrame': '3 months'}, {'measure': 'Pharmacokinetics (plasma drug trough concentrations)', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['colon cancer', 'rectal cancer', 'familial adenomatous polyposis'], 'conditions': ['Colorectal Cancer', 'Precancerous Condition']}, 'referencesModule': {'references': [{'pmid': '20234350', 'type': 'RESULT', 'citation': 'Lynch PM, Ayers GD, Hawk E, Richmond E, Eagle C, Woloj M, Church J, Hasson H, Patterson S, Half E, Burke CA. The safety and efficacy of celecoxib in children with familial adenomatous polyposis. Am J Gastroenterol. 2010 Jun;105(6):1437-43. doi: 10.1038/ajg.2009.758. Epub 2010 Mar 16.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of celecoxib may keep polyps and colorectal cancer from forming in patients with familial adenomatous polyposis.\n\nPURPOSE: This randomized phase I trial is studying the side effects and best dose of celecoxib in treating young patients with a genetic predisposition for familial adenomatous polyposis.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Determine the safety and toxicity of celecoxib in pediatric patients with genotype-positive familial adenomatous polyposis.\n\nSecondary\n\n* Determine the aberrant crypt foci (ACF) and adenoma burden in the entire colorectum of these patients.\n* Eliminate the learning curve in a phase II/III trial (reproducibility of endoscopic techniques, tolerability of procedure).\n* Compare sedation strategies based on local standards (monitored anesthesia care vs conscious sedation).\n* Validate the ACF scoring technique.\n* Establish the short-term (3 month) impact of celecoxib on ACF count in order to determine appropriateness of ACF as a pathologic endpoint in a phase II/III trial.\n\nOUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.\n* Arm II: Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.\n\nPatients undergo colonoscopy at baseline and at 3 months. Patients also complete psychosocial questionnaires at baseline.\n\nBlood samples are collected at baseline to assess the influence of polymorphisms (CYP2C9, uridine diphosphate (UDP)-glucuronosyl transferase, A6, glutathione S-transferase \\[GST\\] M1, and Glutathione S-transferase (GST) theta 1 (GSTT1)) on age of onset of phenotype or number of colorectal polyps. Plasma drug trough levels are assessed at baseline, 1 month, and 3 months.\n\nAfter completion of study treatment, patients are followed periodically for up to 2 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '14 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Diagnosis of familial adenomatous polyposis (FAP) based on genetic predisposition testing\n* Genotype-positive FAP (pathologic Adenomatous polyposis coli (APC) mutation)\n\n * No attenuated FAP genotype, defined by any of the following:\n\n * Mutation at the 5' end of APC and exon 4\n * Exon 9-associated phenotypes\n * 3' region mutations\n* Has an intact colon\n\n * No requirement for colectomy\n * Parent(s) do not desire colectomy (regardless of adenoma burden)\n* Colorectal adenoma burden as assessed by baseline colonoscopy\n\n * No diagnosis of severe dysplasia or greater\n * No more than 10 adenomas ≥ 1 cm\n * No more than 100 adenomas of any size\n * No evidence of anemia (hematocrit \\< 33%)\n* No new diagnosis of carcinoma\n\nPATIENT CHARACTERISTICS:\n\n* White Blood Count (WBC) \\> 3,000/μL\n* Platelet count \\> 100,000/μL\n* Hemoglobin \\> 10.0 g/dL\n* Aspartate aminotransferase/alanine aminotransferase (AST/ALT) \\< 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase \\< 1.5 times ULN\n* Total bilirubin \\< 1.5 times ULN\n* Creatinine \\< 1.5 times ULN\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No history of hypersensitivity to COX-2 inhibitors, sulfonamides, NSAIDs, or salicylates\n* No history of peptic ulcer disease\n* No significant medical or psychiatric problem that, in the opinion of the principal investigator, would make the patient a poor candidate for the study\n* No other unacceptable clinical risk (e.g., previously unknown bleeding diatheses)\n* No invasive carcinoma within the past 5 years\n\nPRIOR CONCURRENT THERAPY:\n\n* More than 3 months since prior investigational agent\n* More than 6 months since prior chemotherapy\n* No prior radiotherapy to the pelvis\n* At least 3 months since prior NSAIDs (at any dose) at a frequency of ≥ 3 times/week\n* At least 1 month since prior NSAIDs (at any dose) at a frequency of \\< 3 times/week\n* At least 1 month since prior nasal steroids\n* Concurrent Nonsteroidal Antiinflammatory Drugs (NSAIDs) allowed provided they are administered ≤ 5 times per month\n* Concurrent orally inhaled steroids allowed provided they are administered for ≤ 4 weeks over a 6-month period\n* Concurrent oral or intravenous (IV) corticosteroids allowed provided they are administered for ≤ 2 consecutive weeks over a 6-month period\n* Concurrent proton pump inhibitors to treat gastric reflux allowed\n* No concurrent nasal steroids except mometasone (Nasonex)\n* No concurrent fluconazole, lithium, or adrenocorticosteroids"}, 'identificationModule': {'nctId': 'NCT00685568', 'briefTitle': 'Celecoxib in Preventing Colorectal Cancer in Young Patients With a Genetic Predisposition for Familial Adenomatous Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Phase I Pilot Toxicity/Methods Validation Study of Celecoxib in Genotype-Positive Children With Familial Adenomatous Polyposis', 'orgStudyIdInfo': {'id': 'ID02-090'}, 'secondaryIdInfos': [{'id': 'MDA-ID-02090'}, {'id': 'CDR0000596468', 'type': 'OTHER', 'domain': 'NCI Clinical Trials'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral celecoxib twice daily for 3 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Drug: celecoxib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Arm II', 'description': 'Patients receive oral placebo twice daily for 3 months in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'celecoxib', 'type': 'DRUG', 'description': 'Orally, twice daily for 3 months; 50 mg tablets. Celecoxib escalating doses starting at 4 mg/kg/day.', 'armGroupLabels': ['Arm I']}, {'name': 'placebo', 'type': 'OTHER', 'description': 'Orally, twice daily for 3 months', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'M. D. Anderson Cancer Center at University of Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Children's Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical School at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Patrick M. Lynch, MD, JD', 'role': 'STUDY_CHAIR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}