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BMS-247550 Plus Capecitabine in Treating Patients With Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00049244
Recruitment Status : Unknown
Verified January 2017 by R-Pharm.
Recruitment status was:  Active, not recruiting
First Posted : January 27, 2003
Last Update Posted : January 30, 2017
National Cancer Institute (NCI)
Information provided by:

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
Breast Cancer Drug: capecitabine Drug: ixabepilone Phase 1

Detailed Description:


  • 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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Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
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
Study Start Date : September 2002

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 120 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00049244

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United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
National Cancer Institute (NCI)
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Study Chair: Linnea Chap, MD Jonsson Comprehensive Cancer Center
Layout table for additonal information Identifier: NCT00049244    
Other Study ID Numbers: BMS-CA163-031
CDR0000258052 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Keywords provided by R-Pharm:
recurrent breast cancer
stage IV breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents