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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

Phase 1
18 Years
Open (Enrolling)
Breast Cancer

Thank you

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


- 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

Inclusion Criteria


- 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



- 18 and over


- Not specified

Menopausal status

- Not specified

Performance status

- ECOG 0-1

Life expectancy

- At least 3 months


- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 9.0 g/dL


- Bilirubin no greater than 1.5 times upper limit of normal (ULN)

- ALT no greater than 2.5 times ULN


- Creatinine less than 1.5 times ULN


- 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


- 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)


Biologic therapy

- See Chemotherapy

- Prior immunotherapy allowed

- No concurrent trastuzumab (Herceptin)

- No concurrent immunotherapy


- 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


- At least 3 weeks since prior radiotherapy

- No prior radiotherapy to more than 25% of the bone marrow

- No concurrent therapeutic radiotherapy


- Not specified


- 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:


Study Design:

Primary Purpose: Treatment

Principal Investigator

Linnea Chap, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Jonsson Comprehensive Cancer Center


United States: Federal Government

Study ID:




Start Date:

September 2002

Completion Date:

Related Keywords:

  • Breast Cancer
  • recurrent breast cancer
  • stage IV breast cancer
  • Breast Neoplasms



Jonsson Comprehensive Cancer Center, UCLA Los Angeles, California  90095-1781