Paclitaxel With or Without Carboplatin in Treating Women With Metastatic Breast Cancer

July 23, 2008 updated by: Theradex

A Randomized, Phase II Trial of Weekly Taxol (Paclitaxel) Versus Weekly Taxol Plus Paraplatin (Carboplatin) as First-Line Chemotherapy in Patients Age 65 Years or Older With Metastatic Breast Cancer

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known if paclitaxel is more effective with or without carboplatin in treating stage IV breast cancer.

PURPOSE: Randomized phase III trial to compare the effectiveness of paclitaxel with or without carboplatin in treating women who have stage IV breast cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVES:

  • Compare the objective response rate in women treated with paclitaxel with or without carboplatin as first-line chemotherapy for metastatic breast cancer.
  • Compare the overall survival, time to disease progression, and duration of response in these patients treated with these regimens.
  • Compare the safety of these regimens in this patient population.
  • Compare the quality of life of these patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to prior adjuvant chemotherapy (yes vs no) and ECOG performance status (0-1 vs 2). Patients are randomized to one of two treatment arms.

  • Arm I: Patients receive paclitaxel IV over 1 hour weekly for 3 weeks.
  • Arm II:Patients receive paclitaxel IV over 1 hour and carboplatin IV over 30 minutes weekly for 3 weeks.

Treatment in both arms continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, before each course during study, and then after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 220 patients will be accrued for this study.

Study Type

Interventional

Phase

  • Phase 3

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
    • Arkansas
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Monterey, California, United States, 93940
        • Monterey Bay Oncology
      • Pomona, California, United States, 91767-3021
        • Wilshire Oncology Medical Group, Inc.
      • Sacramento, California, United States, 95817
        • University of California Davis Cancer Center
    • Connecticut
      • New Britain, Connecticut, United States, 06050
        • New Britain General Hospital
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Center for Hematology and Oncology
      • Hollywood, Florida, United States, 33020
        • Cancer Research Network, Inc.
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic
    • Illinois
      • Berwyn, Illinois, United States, 60402
        • MacNeal Cancer Center
      • Park Ridge, Illinois, United States, 60068
        • Oncology Specialists, SC
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center for Cancer Medicine and Blood Disorders
    • Maryland
      • Baltimore, Maryland, United States, 21236
        • Maryland Hematology/Oncology Associates
    • Missouri
      • Saint Louis, Missouri, United States, 63141
        • St. John's Mercy Medical Center
    • New Jersey
      • Livingston, New Jersey, United States, 07039
        • St. Barnabas Medical Center
    • New York
      • Clifton Springs, New York, United States, 14432
        • Finger Lakes Community Cancer Center
    • Ohio
      • Akron, Ohio, United States, 44302
        • Clinical Hematology & Oncology Service, Inc.
    • Pennsylvania
      • Scranton, Pennsylvania, United States, 18510
        • Scranton Hematology-Oncology
    • Tennessee
      • Knoxville, Tennessee, United States, 37920
        • East Tennessee Oncology/Hematology, P.C.
      • Memphis, Tennessee, United States, 38120
        • West Clinic
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Texas Cancer Care
      • Houston, Texas, United States, 77024
        • Oncology Consultants
      • Temple, Texas, United States, 76508
        • Scott and White Clinic
    • Virginia
      • Fairfax, Virginia, United States, 22031
        • Northern Virginia Oncology Group, P.C.
    • Washington
      • Seattle, Washington, United States, 98109
        • Seattle Cancer Care Alliance
    • Wisconsin
      • Madison, Wisconsin, United States, 53715
        • Dean Medical Center

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

DISEASE CHARACTERISTICS:

  • Histologically or cytologically confirmed breast cancer

    • Must have clinical evidence of stage IV (M1) disease
  • HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown

  • At least 1 measurable lesion

    • At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
    • Patients with bone-only disease are not eligible
  • Ineligible if currently experiencing a complete or partial response to prior hormonal therapy
  • Patients with disease progression after prior response to hormonal therapy are eligible
  • Disease progression without prior hormonal therapy is allowed

  • Stable or asymptomatic brain metastasis allowed if:

    • Other measurable disease exists
    • Cranial irradiation completed and brain metastasis stable for at least 4 weeks before study

  • Hormone receptor status:

    • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Sex:

  • Female

Menopausal status:

  • Pre- or post-menopausal

Performance status:

  • ECOG 0-2

Life expectancy:

  • At least 3 months

Hematopoietic:

  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3

Hepatic:

  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • AST and ALT no greater than 2 times ULN

Renal:

  • Creatinine no greater than 2 times ULN
  • Corrected calcium less than 12 mg/dL

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No documented myocardial infarction within the past 6 months
  • No congestive heart failure
  • No unstable angina
  • No clinically significant pericardial effusion or arrhythmia

Other:

  • No active serious infection
  • No prior significant allergic reactions to drugs containing Cremophor, such as teniposide, cyclosporine, or vitamin K
  • No clinically significant (greater than grade 1) peripheral neuropathy
  • No other serious underlying medical condition that would preclude study participation

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • More than 6 months since prior adjuvant bone marrow or peripheral blood stem cell transplantation
  • More than 6 months since prior adjuvant monoclonal antibody therapy
  • More than 6 months since prior adjuvant vaccine therapy
  • No prior trastuzumab (Herceptin)
  • No concurrent anticancer immunotherapy

Chemotherapy:

  • No prior chemotherapy for metastatic breast cancer
  • More than 6 months since prior adjuvant high-dose chemotherapy
  • More than 6 months since prior adjuvant taxanes or any other adjuvant chemotherapy
  • Prior adjuvant taxanes allowed only if administered every 3 weeks

Endocrine therapy:

  • See Disease Characteristics

  • Any number of prior hormonal therapies for metastatic breast cancer allowed

    • Patients with definite signs of progression may begin study therapy immediately after stopping hormonal therapy
  • No concurrent anticancer hormonal agents (including megestrol)

Radiotherapy:

  • At least 3 weeks since prior radiotherapy (4 weeks for cranial irradiation)
  • No prior radiotherapy to 30% or more of bone marrow
  • No concurrent radiotherapy except for palliation of painful bone metastasis or pathologic fractures to the area of known lytic disease

Surgery:

  • At least 3 weeks since prior major surgery

Other:

  • More than 6 months since prior neoadjuvant therapy
  • No other concurrent anticancer drugs

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
  • Allocation: Randomized

Collaborators and Investigators

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

Sponsor

Theradex

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

January 1, 2001

Study Registration Dates

First Submitted

October 11, 2001

First Submitted That Met QC Criteria

August 4, 2003

First Posted (Estimate)

August 5, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

September 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068992
  • THERADEX-B00-1370
  • BMS-TAX/MEN.13

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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