Breast Cancer
Conditions
Keywords
recurrent breast cancer, stage IV breast cancer
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of combining BMS-247550 with capecitabine in treating patients who have metastatic breast cancer that has not responded to previous chemotherapy with a taxane and an anthracycline.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose of BMS-247550 and capecitabine, on 2 different schedules, in patients with metastatic breast cancer previously treated with a taxane and an anthracycline. * Determine the safety profile of this regimen in these patients. * Determine, preliminarily, any antitumor activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients are assigned to 1 of 2 groups. * Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14. * Group II: Patients receive BMS-247550 IV over 1 hour on days 1-3 and capecitabine as in group I. Treatment in both groups repeats every 3 weeks for 2-18 courses in the absence of disease progression or unacceptable toxicity. Cohorts of 6 patients receive escalating doses of BMS-247550 and capecitabine until the maximum tolerated dose (MTD) is determined for each group. The MTD is defined as the dose at which no more than 1 of 6 patients experiences dose-limiting toxicity. Additional patients are treated at the MTD. Patients are followed for at least 30 days and then every 3 months thereafter. PROJECTED ACCRUAL: Approximately 34-60 patients will be accrued for this study within 8-12 months.
Interventions
DRUGcapecitabine
DRUGixabepilone
Sponsors
National Cancer Institute (NCI)
R-Pharm
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
Inclusion 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
Countries
United States
Outcome results
None listed