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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2003 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00049244
First received: November 12, 2002
Last updated: July 23, 2008
Last verified: January 2003
  Purpose

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 Intervention Phase
Breast Cancer
Drug: capecitabine
Drug: ixabepilone
Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: September 2002
Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00049244

Locations
United States, California
Jonsson Comprehensive Cancer Center, UCLA
Los Angeles, California, United States, 90095-1781
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Investigators
Study Chair: Linnea Chap, MD Jonsson Comprehensive Cancer Center
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00049244     History of Changes
Other Study ID Numbers: CDR0000258052, UCLA-0206011, BMS-CA163-031, NCI-G02-2120
Study First Received: November 12, 2002
Last Updated: July 23, 2008
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent breast cancer
stage IV breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Fluorouracil
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on August 28, 2014