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Trial NCT00020904

Resource URI: http://static.linkedct.org/resource/trials/NCT00020904
linkedct:brief_title BMS-247550 in Treating Women With Metastatic Breast Cancer
linkedct:collaborator_agency <http://static.linkedct.org/resource/collabagency/5381>
linkedct:condition <http://static.linkedct.org/resource/condition/1883>
linkedct:criteria DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed metastatic breast carcinoma - Stage IV or recurrent disease with distant metastases - Most recent prior chemotherapy was docetaxel-based or paclitaxel-based therapy for metastatic disease - Progressed during therapy or within 4 months of last dose OR - Progressed during therapy or within 6 months of last dose if given as adjuvant treatment only - Received prior anthracycline therapy - Bidimensionally measurable metastatic lesion - Bony lesions not considered measurable - No known brain metastases - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 18 and over Menopausal status: - Not specified Sex: - Female Performance status: - ECOG 0-1 Life expectancy: - At least 12 weeks Hematopoietic: - Absolute neutrophil count at least 2,000/mm^3 - Platelet count greater than 125,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - ALT no greater than 2.5 times ULN (5 times ULN if hepatic metastases are present) Renal: - Creatinine no greater than 1.5 times ULN Cardiovascular: - No unstable angina, myocardial infarction, or congestive heart failure within the past 6 months Other: - No grade 2 or greater neuropathy (motor or sensory) - No uncontrolled infection or other medical illness that would preclude study - No psychiatric disorder or other condition that would preclude study - No other malignancy within the past 2 years except nonmelanoma skin cancer or carcinoma in situ of the cervix - No hypersensitivity to agents containing Cremophor EL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 24 hours since prior growth factor - No concurrent trastuzumab (Herceptin) - No concurrent immunotherapy Chemotherapy: - See Disease Characteristics - 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 - No other concurrent chemotherapy Endocrine therapy: - No concurrent hormonal therapy (except hormone replacement therapy) Radiotherapy: - At least 3 weeks since prior radiotherapy, except palliative radiotherapy to less than 20% of the bone marrow, and recovered - No prior radiotherapy to major bone marrow-containing areas (pelvis and lumbar spine) - No prior radiotherapy to target lesion if only measurable lesion - No concurrent therapeutic radiotherapy Surgery: - At least 1 week since prior minor surgery - At least 3 weeks since prior major surgery - Recovered from prior surgery Other: - Recovered from all prior treatment-related toxic effects (alopecia allowed) - No other concurrent experimental anticancer medications
linkedct:description OBJECTIVES: - Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer. - Determine the safety of this drug in these patients. - Determine the duration of response, time to progression, and survival of patients treated with this drug. OUTLINE: This is a multicenter study. Patients 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. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 14-50 patients will be accrued for this study within 12 months.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Female
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age N/A
linkedct:eligibility_minimum_age 18 Years
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date July 11, 2001
linkedct:id NCT00020904
rdfs:label Trial NCT00020904
linkedct:lastchanged_date December 3, 2009
linkedct:lead_sponsor_agency Memorial Sloan-Kettering Cancer Center
linkedct:location <http://static.linkedct.org/resource/location/153340>
linkedct:location <http://static.linkedct.org/resource/location/153989>
linkedct:nct_id NCT00020904
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:official_title A Phase II Study of Epothilone B Analog BMS-247550 in Patients With Taxane-Resistant Metastatic Breast Cancer
linkedct:org_study_id CDR0000068729
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/10274>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00020904>
linkedct:phase Phase 2
linkedct:primary_completion_date January 2003
linkedct:secondary_id BMS-CA163-009
linkedct:secondary_id CPMC-IRB-13916
linkedct:secondary_id MSKCC-01031
linkedct:secondary_id NCI-G01-1967
linkedct:source National Cancer Institute (NCI)
linkedct:start_date February 2001
linkedct:study_design Treatment
linkedct:study_type Interventional
linkedct:summary RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating women who have stage IV or recurrent metastatic breast cancer.
rdf:type linkedct:trials
linkedct:verification_date December 2009