Ignite Creation Date:
2025-12-24 @ 6:25 PM
Ignite Modification Date:
2026-01-04 @ 11:43 AM
Study NCT ID:
NCT00026468
Status:
WITHDRAWN
Last Update Posted:
2013-07-24
First Post:
2001-11-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D015179', 'term': 'Colorectal Neoplasms'}, {'id': 'D003110', 'term': 'Colonic Neoplasms'}, {'id': 'D012004', 'term': 'Rectal 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': 'C025463', 'term': 'sulindac sulfone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Principle Investigator has left the University.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-07', 'completionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-07-23', 'studyFirstSubmitDate': '2001-11-09', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-07-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '1999-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['colon cancer', 'rectal cancer', 'small intestine cancer'], 'conditions': ['Colorectal Cancer', 'Small Intestine Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Exisulind may be effective in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.\n\nPURPOSE: Randomized phase II/III trial to determine the effectiveness of exisulind in preventing the development and growth of polyps in patients who have familial adenomatous polyposis.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the ability of exisulind to inhibit growth and development of duodenal adenomas in patients with familial adenomatous polyposis.\n* Determine the effect on apoptosis in polyp vs mucosal tissue in these patients when treated with this drug.\n\nOUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are randomized to one of two treatment arms.\n\n* Arm I: Patients receive oral exisulind 4 times daily.\n* Arm II: Patients receive oral placebo 4 times daily. Treatment continues for 1 year.\n\nPROJECTED ACCRUAL: A total of 100 patients (50 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* One of the following diagnosis:\n\n * Diagnosis of familial adenomatous polyposis\n\n * Prior total or subtotal colectomy\n * Attenuated adenomatous polyposis coli\n\n * May have colon intact\n* 10-40 duodenal polyps from second portion to 10 cm distal to papilla of Vater\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 to 80\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Hemoglobin at least 10 g/dL\n* Platelet count at least 100,000/mm\\^3\n* No active hematologic disease\n\nHepatic:\n\n* AST and ALT less than 1.5 times upper limit of normal (ULN)\n* Alkaline phosphatase less than 1.5 times ULN\n* No active hepatic disease\n\nRenal:\n\n* Creatinine less than 1.5 mg/dL\n* No active renal disease\n\nOther:\n\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n* No active peptic ulcer disease\n* No serious underlying medical or psychiatric illness that would preclude completion of the study or limit survival\n* No prisoners or institutionalized patients\n* No known allergy to sulindac or related compounds\n* No active internal malignancy within the past 5 years\n* No alcohol or drug abuse within the past 5 years\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 prior non-steroidal anti-inflammatory drugs (NSAIDs) or salicylates more than 10 days a month for the past 3 months\n* No concurrent NSAIDs (e.g., mesalamine, olsalazine, azodisalicylate, salsalate, sulfasalazine)\n* Aspirin for cardiac reasons allowed (81 mg/day or 325 mg twice/week)'}, 'identificationModule': {'nctId': 'NCT00026468', 'briefTitle': 'Exisulind in Preventing Polyps in Patients With Familial Adenomatous Polyposis', 'organization': {'class': 'OTHER', 'fullName': 'University of Utah'}, 'officialTitle': 'Chemoprevention of Duodenal Polyps in Familial Adenomatous Polyposis', 'orgStudyIdInfo': {'id': 'CDR0000069032'}, 'secondaryIdInfos': [{'id': 'R01CA080852', 'link': 'https://reporter.nih.gov/quickSearch/R01CA080852', 'type': 'NIH'}, {'id': 'P30CA042014', 'link': 'https://reporter.nih.gov/quickSearch/P30CA042014', 'type': 'NIH'}, {'id': 'UUMC-IRB-5999-96'}, {'id': 'NCI-H01-0079'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'exisulind', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'James A. DiSario, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Utah'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Utah', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}