Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-31 @ 7:07 AM
Study NCT ID:
NCT00003256
Status:
COMPLETED
Last Update Posted:
2013-02-11
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flavopiridol in Treating Patients With Recurrent Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C077990', 'term': 'alvocidib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2004-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-02-08', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2004-07-30', 'lastUpdatePostDateStruct': {'date': '2013-02-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-08-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-07', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '14871968', 'type': 'RESULT', 'citation': 'Liu G, Gandara DR, Lara PN Jr, Raghavan D, Doroshow JH, Twardowski P, Kantoff P, Oh W, Kim K, Wilding G. A Phase II trial of flavopiridol (NSC #649890) in patients with previously untreated metastatic androgen-independent prostate cancer. Clin Cancer Res. 2004 Feb 1;10(3):924-8. doi: 10.1158/1078-0432.ccr-03-0050.'}]}, 'descriptionModule': {'briefSummary': 'Phase II trial to study the effectiveness of flavopiridol in treating patients with recurrent prostate cancer after hormone therapy. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.', 'detailedDescription': 'OBJECTIVES:\n\nI. Evaluate the clinical effectiveness of flavopiridol in patients with metastatic androgen independent adenocarcinoma of the prostate.\n\nII. Assess the toxic effects of flavopiridol in this patient population.\n\nOUTLINE:\n\nPatients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation. Patients are followed every 3 months until death.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'PATIENT CHARACTERISTICS:\n\n* Performance Status: ECOG 0-2\n* Life Expectancy: At least 3 months\n* WBC at least 3,000/mm3\n* Absolute neutrophil count at least 1,200/mm3\n* Platelet count at least 100,000/mm3\n* Hemoglobin at least 8 g/dL\n* Bilirubin no greater than 1.5 mg/dL\n* SGOT no greater than 2.5 times normal\n* Creatinine no greater than 1.5 mg/dL\n* Prostate-specific antigen at least 10 ng/mL (if bone only disease)\n* No prior or concurrent maligancies within 5 years, except nonmelanoma skin cancer\n* No serious medical illness\n* No cord compression symptoms\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior chemotherapy\n* No prior suramin therapy\n* Prior or concurrent use of luteinizing hormone-releasing hormone allowed (no other concurrent hormonal therapy)\n* No prior anti-androgen therapy within 4 weeks of study\n* At least 4 weeks since prior radiotherapy\n* No prior strontium therapy'}, 'identificationModule': {'nctId': 'NCT00003256', 'briefTitle': 'Flavopiridol in Treating Patients With Recurrent Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Trial of Flavopiridol in Patients With Metastatic Androgen Independent Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000066145'}, 'secondaryIdInfos': [{'id': 'WCCC-CO-9781'}, {'id': 'NCI-T97-0038'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive intravenous flavopiridol over 72 hours every 2 weeks for at least 4 courses. After 2 courses of treatment, patients not experiencing unacceptable toxic effects may receive a dose escalation.', 'interventionNames': ['Drug: alvocidib']}], 'interventions': [{'name': 'alvocidib', 'type': 'DRUG', 'armGroupLabels': ['Arm I']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'Beckman Research Institute, City of Hope', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '53792', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'George Wilding, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, 'responsibleParty': {'type': 'SPONSOR'}}}}