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

January 27, 2017 updated by: R-Pharm

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

R-Pharm

Collaborators

National Cancer Institute (NCI)

Investigators

  • Study Chair: Linnea Chap, MD, Jonsson Comprehensive Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2002

Study Registration Dates

First Submitted

November 12, 2002

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 27, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS-CA163-031
  • UCLA-0206011
  • CDR0000258052 (Registry Identifier: PDQ (Physician Data Query))
  • NCI-G02-2120

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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