BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring recurrent breast cancer, stage IV breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed breast cancer Metastatic disease by radiography or histology Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting No more than 2 prior chemotherapy regimens in the metastatic setting Measurable or evaluable disease Bone lesions not measurable Primary breast lesions not measurable if assessed only by physical exam No active brain metastasis No cerebral edema by CT scan or MRI No progression since prior imaging studies No requirement for steroids No clinical symptoms of brain metastasis Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age 18 and over Sex Not specified Menopausal status Not specified Performance status ECOG 0-1 Life expectancy At least 3 months Hematopoietic Absolute neutrophil count at least 2,000/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9.0 g/dL Hepatic Bilirubin no greater than 1.5 times upper limit of normal (ULN) ALT no greater than 2.5 times ULN Renal Creatinine less than 1.5 times ULN Cardiovascular No uncontrolled or significant cardiovascular disease No myocardial infarction within the past year No uncontrolled angina within the past year No history of congestive heart failure No history of atrial or ventricular arrhythmias No history of second- or third-degree heart block No uncontrolled hypertension Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception HIV negative No hypersensitivity to Cremophor EL or fluorouracil No prior intolerance to fluoropyrimidines No other serious uncontrolled medical disorder or active infection that would preclude study No dementia or altered mental status that would preclude study No grade 2 or greater neuropathy (neuromotor or neurosensory) PRIOR CONCURRENT THERAPY: Biologic therapy See Chemotherapy Prior immunotherapy allowed No concurrent trastuzumab (Herceptin) No concurrent immunotherapy Chemotherapy See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome) At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support No prior epothilone, capecitabine, or continuous-infusion fluorouracil No other concurrent chemotherapy Endocrine therapy Prior hormonal therapy allowed No concurrent hormonal therapy Concurrent hormone replacement therapy allowed Radiotherapy At least 3 weeks since prior radiotherapy No prior radiotherapy to more than 25% of the bone marrow No concurrent therapeutic radiotherapy Surgery Not specified Other At least 3 weeks since prior investigational cytotoxic agents No concurrent warfarin for therapeutic anticoagulation Low-dose warfarin allowed for implanted ports or indwelling catheters No other concurrent experimental anticancer medications No other concurrent antitumor therapy Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study
Sites / Locations
- Jonsson Comprehensive Cancer Center, UCLA