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Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Information provided by:
Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:
NCT00193037
First received: September 12, 2005
Last updated: May 2, 2011
Last verified: May 2011
History of Changes
  Purpose

The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.


Condition Intervention Phase
Breast Cancer
 Drug: Liposomal Doxorubicin
Drug: Docetaxel
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:
  • Overall survival [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: 18 Months ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2001
Study Completion Date: November 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Liposomal Doxorubicin
    Liposomal Doxorubicin
    Drug: Docetaxel
    Docetaxel
Detailed Description:

Upon determination of eligibility, patients will be randomly assigned to one of two treatment arms:

  • Liposomal Doxorubicin
  • Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be eligible for cross over to treatment in the other ARM, provided patient still meets the eligibility laboratory and performance status criteria. The study is not blinded so both the patient and the doctor will know which treatment has been assigned.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

  • Metastatic breast cancer confirmed by biopsy
  • Prior adjuvant/neoadjuvant treatment allowed
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • Age 18 years or older
  • Adequate bone marrow, liver and kidney function
  • Normal heart function
  • Written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

  • Pre-existing moderate peripheral neuropathy
  • History of significant heart disease
  • Meningeal metastases.
  • Prior chemotherapy for metastatic breast cancer
  • No measurable disease (including bone only, pleural effusions, etc.)
  • Receiving Herceptin therapy.
  • Women who are pregnant or lactating.

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00193037

Locations
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Sarah Cannon Research Institute
Ortho Biotech, Inc.
Aventis Pharmaceuticals
Investigators
Principal Investigator: Denise A. Yardley, MD Sarah Cannon Research Institute
  More Information

Additional Information:
Published article in Clinical Breast Cancer  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Denise A. Yardley, M.D., Sarah Cannon Research Institute
ClinicalTrials.gov Identifier: NCT00193037     History of Changes
Other Study ID Numbers: SCRI BRE 43, 20002688
Study First Received: September 12, 2005
Last Updated: May 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Doxorubicin
 Docetaxel
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013