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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Women With Metastatic Breast Cancer  BMS-247550 in Treating Women With Metastatic Breast Cancer
BMS-247550 in Treating Women With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Memorial Sloan-Kettering Cancer Center
Synopsis: 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.
Details: OBJECTIVES: I. Determine the clinical activity of BMS-247550, in terms of tumor response rate, in women with taxane-resistant metastatic breast cancer. II. Determine the safety of this drug in these patients. III. Determine the duration of response, time to progression, and survival of patients treated with this drug. PROTOCOL 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --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/mm3; Platelet count greater than 125,000/mm3 - 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CliffordHudis, Study Chair, Memorial Sloan-Kettering Cancer Center
Memorial Sloan-Kettering Cancer Center
New York City, New York, 10021
United States
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000068729; MSKCC-01031,CPMC-IRB-13916,NCI-G01-1967,BMS-CA163-009
Study Start Date: February 2001
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00020904
Other Stage 4 Breast Cancer Studies:
1. High Dose Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Standard Therapy in Treating Patients With Locally Recurrent or Metastatic Breast Cancer
2. Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
3. Edotecarin in Treating Women With Locally Advanced or Metastatic Breast Cancer That Has Not Responded to Anthracycline and Taxane Chemotherapy
4. Lonafarnib, Trastuzumab, and Paclitaxel in Treating Patients With HER2/neu-Overexpressing Stage IIIB, Stage IIIC, or Stage IV Breast Cancer
5. Monoclonal Antibody Therapy in Treating Women With Locally Advanced or Metastatic Breast Cancer Previously Treated With Combination Chemotherapy
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
BMS-247550 in Treating Women With Metastatic Breast Cancer
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