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Completed

NCT Number: NCT00193037

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Tennessee Oncology

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Liposomal Doxorubicin

Drug

Liposomal Doxorubicin

Other names: Doxil

docetaxel

Drug

Docetaxel

Other names: Taxotere

Primary outcomes

  1. Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

    Time frame: 18 Months

    ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.

Secondary outcomes

  1. Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.

    Time frame: 18 Months

    PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.

Sponsors and collaborators

Lead sponsor

SCRI Development Innovations, LLC

Other

Collaborators

  • Aventis Pharmaceuticals
  • Ortho Biotech, Inc.

Registry information

Official study title

A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

Important dates

Study start
2001
Primary completion
2008
Study completion
2009
First posted
Sep 19, 2005
Registry last updated
Jul 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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