BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
This trial is active, not recruiting.
|Sponsor||Jonsson Comprehensive Cancer Center|
|Collaborator||National Cancer Institute (NCI)|
|Start date||September 2002|
|Trial identifier||NCT00049244, BMS-CA163-031, CDR0000258052, NCI-G02-2120, UCLA-0206011|
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.
Male or female participants at least 18 years old.
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
|Official title||A Phase I Study of BMS-247550 in Combination With Capecitabine in Patients With Metastatic Breast Cancer Previously Treated With a Taxane and an Anthracycline|
|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.|
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