Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-31 @ 1:26 PM
Study NCT ID:
NCT01481233
Status:
WITHDRAWN
Last Update Posted:
2013-09-27
First Post:
2011-11-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oral Colchicine in Men With Castrate Resistant Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003078', 'term': 'Colchicine'}], 'ancestors': [{'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Due to funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2013-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-26', 'studyFirstSubmitDate': '2011-11-11', 'studyFirstSubmitQcDate': '2011-11-23', 'lastUpdatePostDateStruct': {'date': '2013-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PSA Response rate', 'timeFrame': '63 days (3 cycles of treatment)', 'description': 'Determine the PSA response rate to continuous low dose oral colchicine'}], 'secondaryOutcomes': [{'measure': 'Response rate', 'timeFrame': '63 days (3 cycles)', 'description': 'Determine the progression free survival'}, {'measure': 'Toxicity grading', 'timeFrame': 'One year', 'description': 'Determine the safety and tolerability of continuous low dose oral colchicine'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['oral colchicine', 'castrate-resistant prostate cancer', 'failed taxotere based chemotherapy'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the prostate specific antigen response to continuous low dose oral colchicine.', 'detailedDescription': 'The investigators propose a simple phase II trial of oral colchicine at the standard prophylactic dose utilized for gout in men with CRPCa who have failed taxotere based chemotherapy. The investigators will utilize a simple modified Simon 2-stage design. The investigators plan to enroll 40 men for the study. The men should have completed prior taxotere based therapy or any other therapy post-taxotere including cabazitaxel one month prior to receipt of colchicine on trial. Staging with a baseline bone scan, CT and PSA as well as routine CBC, CMP and PAP. The dose of the drug can be escalated as tolerated to a maximum of 1.2 mg bid. The patient would be seen at 21 day intervals. After every 3 cycles of treatment, patient would be restaged with CT and bone scan. Patients with stable disease, partial response or complete response would continue therapy until either disease progression or intolerable toxicity after which the patient would be taken off study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Castrate resistant prostate cancer\n* Failure or intolerance of taxotere or cabazitaxel-based chemotherapy or abiraterone administered for castrate resistant prostate cancer is allowed\n* Age \\> 18 years and ability to provide informed consent\n* ECOG performance status of 0, 1 or 2\n* No prior use of colchicine within the last 2 years\n* No chemotherapy, hormonal therapy, immunotherapy or radiation therapy within 1 month of day 1, cycle 1\n\nExclusion Criteria:\n\n* Inability to provide informed consent\n* Hypersensitivity to colchicine\n* Severe renal, gastrointestinal or hepatic disorders\n* Pre-existing blood dyscrasia\n* PLT \\< 100K, ANC \\< 1000\n* Serum Cr \\> 2 x ULN\n* Bilirubin \\> 2 ULN\n* AST \\> 2 x ULN\n* Concurrent use of CYP3A4 inhibitors which may increase drug levels and toxicity'}, 'identificationModule': {'nctId': 'NCT01481233', 'briefTitle': 'Oral Colchicine in Men With Castrate Resistant Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Phase II Trial of Oral Colchicine in Men With Castrate-Resistant Prostate Cancer Who Have Failed Taxotere-Based Chemotherapy', 'orgStudyIdInfo': {'id': 'PSHCI 09-023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single arm', 'description': 'Colchicine 0.5 mg BID x 21 days', 'interventionNames': ['Drug: Colchicine']}], 'interventions': [{'name': 'Colchicine', 'type': 'DRUG', 'otherNames': ['Colcrys'], 'description': 'Colchicine 0.6 mg bid to a maximum of 1.2 mg bid', 'armGroupLabels': ['Single arm']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joseph J Drabick, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'Joseph Drabick', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}