Ignite Creation Date:
2025-12-25 @ 1:44 AM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT00023894
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016889', 'term': 'Endometrial Neoplasms'}], 'ancestors': [{'id': 'D014594', 'term': 'Uterine Neoplasms'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C077990', 'term': 'alvocidib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-05', 'completionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2001-09-13', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['recurrent endometrial carcinoma'], 'conditions': ['Endometrial Cancer']}, 'referencesModule': {'references': [{'pmid': '15978659', 'type': 'RESULT', 'citation': 'Grendys EC Jr, Blessing JA, Burger R, Hoffman J. A phase II evaluation of flavopiridol as second-line chemotherapy of endometrial carcinoma: a Gynecologic Oncology Group study. Gynecol Oncol. 2005 Aug;98(2):249-53. doi: 10.1016/j.ygyno.2005.05.017.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.\n\nPURPOSE: Phase II trial to study the effectiveness of flavopiridol in treating patients who have recurrent or persistent endometrial cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the antitumor activity of flavopiridol in patients with recurrent or persistent endometrial carcinoma.\n* Determine the nature and degree of toxicity of this drug in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive flavopiridol IV over 1 hour on days 1-3. Treatment repeats every 21 days for at least 2 courses in the absence of disease progression or unacceptable toxicity.\n\nPatients are followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.\n\nPROJECTED ACCRUAL: A total of 19-51 patients will be accrued for this study within 10-24 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed primary endometrial carcinoma\n\n * Recurrent or persistent disease\n * Refractory to curative therapy or established treatment\n* Previously treated with only 1 prior cytotoxic chemotherapy regimen (either single agent or combination therapy) for endometrial carcinoma\n\n * Initial treatment may include high-dose, consolidation, or extended therapy administered after surgical or non-surgical assessment\n* At least 1 unidimensionally measurable lesion\n\n * At least 20 mm by conventional techniques OR\n * At least 10 mm by spiral CT scan\n * At least 1 target lesion outside previously irradiated field\n* Ineligible for higher priority Gynecologic Oncology Group (GOG) protocol, defined as any active GOG phase III protocol for the same patient population\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Any age\n\nPerformance status:\n\n* GOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* SGOT no greater than 2.5 times ULN\n* Alkaline phosphatase no greater than 2.5 times ULN\n* PT/PTT normal\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No prior thromboembolic events or thrombophlebitis\n* No prior recent myocardial infarction\n* No prior angina\n* No prior cerebrovascular accident\n* No prior transient ischemic attacks\n\nOther:\n\n* No other invasive malignancy within the past 5 years except nonmelanoma skin cancer\n* No grade 2 or greater sensory or motor neuropathy\n* No active infection requiring antibiotics\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 3 weeks since prior biologic or immunologic agents for endometrial carcinoma\n\nChemotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior chemotherapy for endometrial carcinoma and recovered\n\nEndocrine therapy:\n\n* At least 1 week since prior hormonal therapy for endometrial carcinoma\n* Concurrent hormone replacement therapy allowed\n\nRadiotherapy:\n\n* See Disease Characteristics\n* At least 3 weeks since prior radiotherapy for endometrial carcinoma and recovered\n\nSurgery:\n\n* At least 3 weeks since prior surgery for endometrial carcinoma and recovered\n* At least 6 months since prior re-vascularization procedures (e.g., coronary artery bypass graft, carotid endarterectomy or bypass, or angioplasty with or without stents)\n\nOther:\n\n* At least 3 weeks since other prior therapy for endometrial carcinoma\n* At least 6 months since prior thrombolytic procedures\n* No prior cyclin-dependent kinase inhibitors\n* No prior anticancer therapy that would preclude study\n* No concurrent amifostine or other protective reagents'}, 'identificationModule': {'nctId': 'NCT00023894', 'briefTitle': 'Flavopiridol in Treating Patients With Recurrent or Persistent Endometrial Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Evaluation of Flavopiridol (NSC# 649890) in the Treatment of Recurrent or Persistent Endometrial Carcinoma', 'orgStudyIdInfo': {'id': 'CDR0000068874'}, 'secondaryIdInfos': [{'id': 'GOG-0129M'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'alvocidib', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294-3300', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham Comprehensive Cancer Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '90095-1781', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Jonsson Comprehensive Cancer Center, UCLA', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Community Hospital of Los Gatos', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'Chao Family Comprehensive Cancer Center', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}, {'zip': '80010', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado Cancer Center', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '20307-5001', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'Walter Reed Army Medical Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33612-9497', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '60612-3864', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': "Rush-Presbyterian-St. Luke's Medical Center", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Cancer Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46202-5289', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Indiana University Cancer Center', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '52242-1009', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '40536-0084', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Albert B. Chandler Medical Center, University of Kentucky', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '20892-1182', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Tuft-New England Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '01605-2982', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'University of Massachusetts Memorial Medical Center - University Campus', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Cancer Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905-0001', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic Cancer Center', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '39216-4505', 'city': 'Jackson', 'state': 'Mississippi', 'country': 'United States', 'facility': 'University of Mississippi Medical Center', 'geoPoint': {'lat': 32.29876, 'lon': -90.18481}}, {'zip': '39534-2576', 'city': 'Keesler Air Force Base', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Keesler Medical Center - Keesler AFB', 'geoPoint': {'lat': 30.41078, 'lon': -88.92188}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '08103-1489', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cooper Hospital/University Medical Center', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '11203', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Health Science Center at Brooklyn', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '14263-0001', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'North Shore University Hospital', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan-Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11794-8091', 'city': 'Stony Brook', 'state': 'New York', 'country': 'United States', 'facility': 'State University of New York Health Sciences Center - Stony Brook', 'geoPoint': {'lat': 40.92565, 'lon': -73.14094}}, {'zip': '27599-7295', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Lineberger Comprehensive Cancer Center, UNC', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke Comprehensive Cancer Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '27157-1065', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '45267-0526', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Barrett Cancer Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ireland Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Taussig Cancer Center', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210-1240', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital - Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '73190', 'city': 'Oklahoma City', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'University of Oklahoma College of Medicine', 'geoPoint': {'lat': 35.46756, 'lon': -97.51643}}, {'zip': '19001-3788', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '17033-0850', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Milton S. Hershey Medical Center', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19104-4283', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107-5541', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Kimmel Cancer Center of Thomas Jefferson University - Philadelphia', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19111', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Fox Chase Cancer Center', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '29425-2233', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Brookview Research, Inc.', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390-9032', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Simmons Cancer Center - Dallas', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77555-0587', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'CCOP - M.D. Anderson Research Base', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030-4009', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas - MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'Fletcher Allen Health Care - Medical Center Campus', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cancer Center at the University of Virginia', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '98109-1024', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Fred Hutchinson Cancer Research Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'Tacoma General Hospital', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}, {'zip': '1450', 'city': 'Camperdown', 'state': 'New South Wales', 'country': 'Australia', 'facility': 'Australia New Zealand Gynaecological Oncology Trials Group', 'geoPoint': {'lat': -33.88965, 'lon': 151.17642}}, {'zip': 'T2N 4N2', 'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center - Calgary', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}, {'zip': 'N-0310', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Norwegian Radium Hospital', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': 'B15 2TT', 'city': 'Birmingham', 'state': 'England', 'country': 'United Kingdom', 'facility': 'University of Birmingham', 'geoPoint': {'lat': 52.48142, 'lon': -1.89983}}], 'overallOfficials': [{'name': 'Edward C. Grendys, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Robert H. Lurie Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynecologic Oncology Group', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}