BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
OBJECTIVES:
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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.
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Determine the safety profile of this regimen in these patients.
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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.
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Group I: Patients receive BMS-247550 IV over 3 hours on day 1 and oral capecitabine twice daily on days 1-14.
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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.
Study Design
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Histologically or cytologically confirmed breast cancer
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Metastatic disease by radiography or histology
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Must have received prior chemotherapy with a taxane and an anthracycline in the adjuvant or metastatic setting
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No more than 2 prior chemotherapy regimens in the metastatic setting
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Measurable or evaluable disease
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Bone lesions not measurable
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Primary breast lesions not measurable if assessed only by physical exam
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No active brain metastasis
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No cerebral edema by CT scan or MRI
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No progression since prior imaging studies
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No requirement for steroids
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No clinical symptoms of brain metastasis
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Hormone receptor status:
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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
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Absolute neutrophil count at least 2,000/mm^3
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Platelet count at least 100,000/mm^3
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Hemoglobin at least 9.0 g/dL
Hepatic
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Bilirubin no greater than 1.5 times upper limit of normal (ULN)
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ALT no greater than 2.5 times ULN
Renal
- Creatinine less than 1.5 times ULN
Cardiovascular
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No uncontrolled or significant cardiovascular disease
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No myocardial infarction within the past year
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No uncontrolled angina within the past year
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No history of congestive heart failure
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No history of atrial or ventricular arrhythmias
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No history of second- or third-degree heart block
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No uncontrolled hypertension
Other
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Not pregnant or nursing
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Negative pregnancy test
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Fertile patients must use effective contraception
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HIV negative
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No hypersensitivity to Cremophor EL or fluorouracil
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No prior intolerance to fluoropyrimidines
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No other serious uncontrolled medical disorder or active infection that would preclude study
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No dementia or altered mental status that would preclude study
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No grade 2 or greater neuropathy (neuromotor or neurosensory)
PRIOR CONCURRENT THERAPY:
Biologic therapy
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See Chemotherapy
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Prior immunotherapy allowed
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No concurrent trastuzumab (Herceptin)
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No concurrent immunotherapy
Chemotherapy
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See Disease Characteristics
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At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas, mitomycin, or doxorubicin HCl liposome)
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At least 2 years since prior high-dose chemotherapy with bone marrow transplantation or peripheral blood stem cell support
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No prior epothilone, capecitabine, or continuous-infusion fluorouracil
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No other concurrent chemotherapy
Endocrine therapy
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Prior hormonal therapy allowed
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No concurrent hormonal therapy
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Concurrent hormone replacement therapy allowed
Radiotherapy
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At least 3 weeks since prior radiotherapy
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No prior radiotherapy to more than 25% of the bone marrow
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No concurrent therapeutic radiotherapy
Surgery
- Not specified
Other
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At least 3 weeks since prior investigational cytotoxic agents
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No concurrent warfarin for therapeutic anticoagulation
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Low-dose warfarin allowed for implanted ports or indwelling catheters
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No other concurrent experimental anticancer medications
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No other concurrent antitumor therapy
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Concurrent bisphosphonates for palliation of bone metastases allowed if initiated before study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Jonsson Comprehensive Cancer Center, UCLA | Los Angeles | California | United States | 90095-1781 |
Sponsors and Collaborators
- R-Pharm
- National Cancer Institute (NCI)
Investigators
- Study Chair: Linnea Chap, MD, Jonsson Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BMS-CA163-031
- UCLA-0206011
- CDR0000258052
- NCI-G02-2120