Ignite Creation Date:
2025-12-25 @ 1:11 AM
Ignite Modification Date:
2025-12-27 @ 1:32 AM
Study NCT ID:
NCT00016393
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2001-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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': 'C430592', 'term': 'ixabepilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2004-02', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-20', 'studyFirstSubmitDate': '2001-05-06', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-06-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage IV prostate cancer', 'recurrent prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '16314632', 'type': 'RESULT', 'citation': 'Hussain M, Tangen CM, Lara PN Jr, Vaishampayan UN, Petrylak DP, Colevas AD, Sakr WA, Crawford ED; Southwest Oncology Group. Ixabepilone (epothilone B analogue BMS-247550) is active in chemotherapy-naive patients with hormone-refractory prostate cancer: a Southwest Oncology Group trial S0111. J Clin Oncol. 2005 Dec 1;23(34):8724-9. doi: 10.1200/JCO.2005.02.4448.'}]}, '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 BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer.\n* Determine the overall survival and progression-free survival rate in patients treated with this drug.\n* Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug.\n* Evaluate the qualitative and quantitative toxic effects of this regimen in these patients.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR.\n\nPatients are followed every 3 months for 1 year and then every 6 months for 2 years.\n\nPROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': "DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1)\n* Unresponsive or refractory to prior hormonal therapy by at least 1 of the following:\n\n * Progression of unidimensionally measurable lesion outside of a prior radiation port\n * Progression of non-measurable disease (e.g., bone scan)\n* Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart\n* PSA at least 5 ng/mL\n* No brain metastases\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Zubrod 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute granulocyte count at least 1,500/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than upper limit of normal (ULN)\n* SGOT or SGPT no greater than 2.5 times ULN\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL OR\n* Creatinine clearance at least 40 mL/min\n\nOther:\n\n* No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission\n* No other concurrent significant active illness that would preclude study participation\n* Recovered from major infections\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 28 days since prior biologic therapy and recovered\n* No more than 1 prior biologic (non-cytotoxic) therapy\n* No concurrent biological response modifiers\n\nChemotherapy:\n\n* No prior chemotherapy for this disease\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* At least 28 days since prior flutamide or ketoconazole\n* At least 42 days since prior bicalutamide or nilutamide\n* No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy\n* No concurrent corticosteroids\n\nRadiotherapy:\n\n* See Disease Characteristics\n* Prior radiotherapy to less than 30% of bone marrow allowed\n* No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium\n* At least 28 days since prior radiotherapy and recovered\n* No concurrent radiotherapy\n\nSurgery:\n\n* Recovered from prior surgery\n* Prior orchiectomy allowed\n\nOther:\n\n* No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer)\n* Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)"}, 'identificationModule': {'nctId': 'NCT00016393', 'briefTitle': 'BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Phase II Trial of Epothilone B Analogue BMS-247550 (NSC #710428) (IND 59699) Administered Every 21 Days in Patients With Hormone Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000068629'}, 'secondaryIdInfos': [{'id': 'SWOG-S0111'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ixabepilone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '90033-0804', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'USC/Norris Comprehensive Cancer Center and Hospital', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis Cancer Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '30342-1701', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'CCOP - Atlanta Regional', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60141', 'city': 'Hines', 'state': 'Illinois', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)', 'geoPoint': {'lat': 41.85364, 'lon': -87.8395}}, {'zip': '66160-7390', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '67214-3882', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'CCOP - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '67218', 'city': 'Wichita', 'state': 'Kansas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Wichita', 'geoPoint': {'lat': 37.69224, 'lon': -97.33754}}, {'zip': '70112', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'MBCCOP - LSU Health Sciences Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '71130-3932', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Louisiana State University Health Sciences Center - Shreveport', 'geoPoint': {'lat': 32.52515, 'lon': -93.75018}}, {'zip': '48109-0330', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Comprehensive Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48201-1379', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Barbara Ann Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48201-1932', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Detroit', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49503', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'CCOP - Grand Rapids', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center at Columbia University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center at University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '97201-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Cancer Institute', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97207', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Portland', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '29425', 'city': 'Charleston', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Hollings Cancer Center at Medical University of South Carolina', 'geoPoint': {'lat': 32.77632, 'lon': -79.93275}}, {'zip': '29303', 'city': 'Spartanburg', 'state': 'South Carolina', 'country': 'United States', 'facility': 'CCOP - Upstate Carolina', 'geoPoint': {'lat': 34.94957, 'lon': -81.93205}}, {'zip': '38104', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Danville Radiation Therapy Center', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Harrington Cancer Center', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '79106', 'city': 'Amarillo', 'state': 'Texas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Amarillo', 'geoPoint': {'lat': 35.222, 'lon': -101.8313}}, {'zip': '78234-6200', 'city': 'Fort Sam Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Brooke Army Medical Center', 'geoPoint': {'lat': 29.45303, 'lon': -98.4417}}, {'zip': '78229-3900', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center at San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - San Antonio (Murphy)', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'CCOP - Scott and White Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute at Swedish Medical Center - First Hill Campus', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98108', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Seattle', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Maha Hadi A. Hussain, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Michigan Rogel Cancer Center'}, {'name': 'Primo N. Lara, MD', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'SWOG Cancer Research Network', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}