Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief 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.
Detailed 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.
Interventions
Sponsors
Study design
Eligibility
Inclusion 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
Countries
United States