Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2026-02-22 @ 6:44 PM
Study NCT ID:
NCT00087256
Status:
TERMINATED
Last Update Posted:
2013-01-07
First Post:
2004-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}], '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'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'whyStopped': 'For scientific, logistic, and administrative reasons.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-04', 'studyFirstSubmitDate': '2004-07-08', 'studyFirstSubmitQcDate': '2004-07-09', 'lastUpdatePostDateStruct': {'date': '2013-01-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine whether celecoxib 400 mg bid for 3 years will decrease the incidence of adenomatous polyps of the colon and rectum in participants with Stage I adenocarcinoma of the colon.', 'timeFrame': '60 months'}], 'secondaryOutcomes': [{'measure': 'To access whether celecoxib will increase disease-free survival.', 'timeFrame': '60 months'}, {'measure': 'To access whether celecoxib therapy affects self-reported symptoms and health-related quality of life.', 'timeFrame': '60 months'}, {'measure': 'To describe the quality of life in early stage colon cancer patients.', 'timeFrame': '42 months'}, {'measure': 'To evaluate if the benefits from celecoxib are more pronounced in a cohort of participants whose primary colon tumors and polyps express COX-2.', 'timeFrame': '60 months'}, {'measure': 'To examine the expression of signaling targets such as serine/threonine kinase (AKT) extracellular signal-regulated kinase (ERK2), and endoplasmic reticulum Ca2+-ATPases in the index tumor and polyps.', 'timeFrame': '60 months'}, {'measure': 'To monitor the toxicity and safety of celecoxib in this population.', 'timeFrame': '60 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['stage I colon cancer', 'adenocarcinoma of the colon'], 'conditions': ['Colorectal Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development of cancer. It is not yet known whether celecoxib is effective in preventing polyps in patients with colon cancer.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of celecoxib in preventing the development of polyps in patients who have undergone surgery for stage I colon cancer.', 'detailedDescription': 'OBJECTIVES:\n\nPrimary\n\n* Compare celecoxib vs placebo, in terms of decreasing the incidence of adenomatous polyps of the colon and rectum, in patients with resected stage I adenocarcinoma of the colon.\n\nSecondary\n\n* Compare disease-free survival of patients treated with these regimens.\n* Compare the effect of these regimens on self-reported symptoms and health-related quality of life of these patients.\n* Compare the quality of life of patients treated with these regimens.\n* Compare the benefits of celecoxib in patients with primary tumors or polyps that express cyclo-oxygenase-2 (COX-2) with those that do not express COX-2.\n* Compare the expression of signaling targets such as serine/threonine AKT, extracellular signal-regulated kinase 2 (ERK2), and endoplasmic reticulum Ca+2- ATPases in the index tumor and polyps.\n* Determine the toxicity and safety of celecoxib in these patients.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to gender, tumor stage (T1 vs T2), age (≤ 49 vs 50 to 59 vs ≥ 60 years), and current aspirin use (yes vs no). Patients are randomized to 1 of 2 treatment arms.\n\n* Arm I: Patients receive oral celecoxib twice daily for 3 years.\n* Arm II: Patients receive oral placebo twice daily for 3 years. In both arms, treatment continues in the absence of unacceptable toxicity or the diagnosis of invasive colon cancer, carcinoma in situ of the colon or rectum, or a non-colon primary cancer.\n\nQuality of life is assessed at baseline and then at 6, 12, 24, 36, and 42 months.\n\nPatients are followed at 6 months and at 2 years.\n\nPROJECTED ACCRUAL: A total of 1,200 patients (600 per treatment arm) will be accrued for this study within 2.5 years.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the colon\n\n * Stage I disease\n * Distal border of tumor ≥ 12 cm from the anal verge\n* Tumor completely resected within the past 90 days\n* Must have undergone a preoperative or postoperative colonoscopy to the cecum (or small bowel anastomosis) within the past 90 days\n\n * All observed polyps must have been removed\n* Patients with a history suggestive of hereditary non-polyposis colorectal cancer (HNPCC) must have a normal microsatellite instability status by immunohistochemistry or polymerase chain reaction\n\n * Patients with family history of colon cancer who have not been diagnosed with HNPCC are eligible\n* No prior familial adenomatous polyposis\n* No prior invasive cancer or carcinoma in situ of the colon or rectum\n* No clinical or radiologic evidence of metastatic disease\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* Zubrod 0-1\n\nLife expectancy\n\n* At least 10 years\n\nHematopoietic\n\n* Complete blood count normal\n* Platelet count normal\n\nHepatic\n\n* Aspartate aminotransferase (AST) normal\n* Bilirubin normal\n* Alkaline phosphatase normal\n\nRenal\n\n* Creatinine normal\n\nCardiovascular\n\n* No active ischemic heart disease\n* No New York Heart Association class III or IV heart disease\n* No myocardial infarction within the past 6 months\n* No symptomatic arrhythmia\n* No symptomatic peripheral vascular disease or carotid disease that would preclude study participation\n\nPulmonary\n\n* No aspirin-sensitive asthma\n\nGastrointestinal\n\n* No history of inflammatory bowel disease\n* No history of upper gastrointestinal bleeding\n* No history of duodenal or gastric ulcer\n\nOther\n\n* No known hypersensitivity to any COX-2 inhibitor, NSAIDs, aspirin, or sulfonamides\n* No non-colorectal malignancy within the past 5 years except carcinoma in situ of the cervix, melanoma in situ, or basal cell or squamous cell skin cancer\n* No other disease that would preclude study participation\n* No psychiatric disorders, including history of clinical depression or addictive disorders, that would preclude giving informed consent or long-term compliance\n* No rheumatologic or skeletal disorders requiring chronic NSAIDs or steroid therapy\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* Not specified\n\nEndocrine therapy\n\n* Not specified\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* See Disease Characteristics\n\nOther\n\n* No other concurrent investigational agents for colon cancer\n* No concurrent chronic use of other cyclo-oxygenase-2 (COX-2) inhibitors, non-steroidal anti-inflammatory drugs (NSAIDs), or salicylates (e.g., aspirin)\n\n * Chronic use is defined as use for more than an average of 3 days per month\n\n * Concurrent NSAIDs allowed for up to 10 consecutive days for temporary relief due to inflammatory syndromes, injury, or postoperative pain\n * Cardioprotective doses of aspirin (≤ 81 mg/day or 325 mg every other day) allowed\n* No concurrent fluconazole or lithium'}, 'identificationModule': {'nctId': 'NCT00087256', 'briefTitle': 'Celecoxib in Preventing Polyps in Patients Who Have Undergone Surgery for Stage I Colon Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'NSABP Foundation Inc'}, 'officialTitle': 'Celecoxib Polyp Prevention Trial in Participants With Resected Stage I Colon Cancer', 'orgStudyIdInfo': {'id': 'NSABP P-3'}, 'secondaryIdInfos': [{'id': 'NSABP-P-3'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Arm 1: placebo', 'description': 'one placebo capsule taken orally twice a day for 3 years', 'interventionNames': ['Drug: Celecoxib']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2: celecoxib', 'description': 'one 400 mg capsule taken orally twice a day for 3 years', 'interventionNames': ['Other: placebo']}], 'interventions': [{'name': 'Celecoxib', 'type': 'DRUG', 'otherNames': ['Celebrex'], 'armGroupLabels': ['Arm 1: placebo']}, {'name': 'placebo', 'type': 'OTHER', 'armGroupLabels': ['Arm 2: celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15215', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}], 'overallOfficials': [{'name': 'Norman Wolmark, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NSABP Foundation Inc'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NSABP Foundation Inc', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}