Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-25 @ 7:06 PM
Study NCT ID:
NCT00020904
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2001-07-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
BMS-247550 in Treating Women With Metastatic Breast Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C430592', 'term': 'ixabepilone'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'TREATMENT'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2001-07-11', 'studyFirstSubmitQcDate': '2003-09-09', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-09-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage IV breast cancer', 'recurrent breast cancer'], 'conditions': ['Breast Cancer']}, '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 women who have stage IV or recurrent metastatic breast cancer.', 'detailedDescription': "OBJECTIVES:\n\n* Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer.\n* Determine the safety of this drug in these patients.\n* Determine the duration of response, time to progression, and survival of patients treated with this drug.\n\nOUTLINE: This is a multicenter study.\n\nPatients receive BMS-247550 IV over 3 hours on day 1. Treatment continues every 3 weeks for 4-18 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 4 additional courses beyond CR. Responding patients may receive additional courses at the investigator's discretion.\n\nPatients are followed every 3 months.\n\nPROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed metastatic breast carcinoma\n\n * Stage IV or recurrent disease with distant metastases\n* Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease\n\n * Progressed during therapy or within 4 months of last dose OR\n * Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only\n* Received prior anthracycline therapy\n* Bidimensionally measurable metastatic lesion\n\n * Bony lesions not considered measurable\n* No known brain metastases\n* Hormone receptor status:\n\n * Not specified\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nMenopausal status:\n\n* Not specified\n\nSex:\n\n* Female\n\nPerformance status:\n\n* ECOG 0-1\n\nLife expectancy:\n\n* At least 12 weeks\n\nHematopoietic:\n\n* Absolute neutrophil count at least 2,000/mm\\^3\n* Platelet count greater than 125,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times upper limit of normal (ULN)\n* ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present)\n\nRenal:\n\n* Creatinine no greater than 1.5 times ULN\n\nCardiovascular:\n\n* No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months\n\nOther:\n\n* No grade 2 or greater neuropathy (motor or sensory)\n* No uncontrolled infection or other medical illness that would preclude study\n* No psychiatric disorder or other condition that would preclude study\n* No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix\n* No hypersensitivity to agents containing Cremophor EL\n* Not pregnant or nursing\n* Negative pregnancy test\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* At least 24 hours since prior growth factor\n* No concurrent trastuzumab (Herceptin)\n* No concurrent immunotherapy\n\nChemotherapy:\n\n* See Disease Characteristics\n* No more than 1 prior chemotherapy regimen for metastatic disease except an anthracycline-containing regimen as first-line therapy and a taxane as second-line therapy\n* No other concurrent chemotherapy\n\nEndocrine therapy:\n\n* No concurrent hormonal therapy (except hormone replacement therapy)\n\nRadiotherapy:\n\n* At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered\n* No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine)\n* No prior radiotherapy to target lesion if only measurable lesion\n* No concurrent therapeutic radiotherapy\n\nSurgery:\n\n* At least 1 week since prior minor surgery\n* At least 3 weeks since prior major surgery\n* Recovered from prior surgery\n\nOther:\n\n* Recovered from all prior treatment-related toxic effects (alopecia allowed)\n* No other concurrent experimental anticancer medications'}, 'identificationModule': {'nctId': 'NCT00020904', 'briefTitle': 'BMS-247550 in Treating Women With Metastatic Breast Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer', 'orgStudyIdInfo': {'id': '01-031'}, 'secondaryIdInfos': [{'id': 'CDR0000068729', 'type': 'REGISTRY', 'domain': 'PDQ (Physician Data Query)'}, {'id': 'BMS-CA163-009'}, {'id': 'CPMC-IRB-13916'}, {'id': 'NCI-G01-1967'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'ixabepilone', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'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': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Herbert Irving Comprehensive Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Clifford A. Hudis, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}]}}}