bms-247550 in treating women with metastatic breast cancer

Conditions: Breast Cancer

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.

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.

Eligibility 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

Keywords: stage iv breast cancer recurrent breast cancer