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
18 Years
N/A
Both
Breast Cancer
Trial Information
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
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.
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
Type of Study:
Interventional
Study Design:
Primary Purpose: Treatment
Principal Investigator
Linnea Chap, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Jonsson Comprehensive Cancer Center
Authority:
United States: Federal Government
Study ID:
CDR0000258052
NCT ID:
NCT00049244
Start Date:
September 2002
Completion Date:
Related Keywords:
- Breast Cancer
- recurrent breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
