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

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute Ortho Biotech, Inc. Aventis Pharmaceuticals
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193037

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 II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Crossover Assignment, Safety/Efficacy Study
Official Title:	A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall survival

Secondary Outcome Measures:

Time to progression
Duration of response
Time to response
Median time to off study
Quality of life
Overall toxicity

Estimated Enrollment:	120
Study Start Date:	February 2001

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

No publications provided

Responsible Party:	Sarah Cannon Research Institute ( Denise A. Yardley, M.D. )
Study ID Numbers:	SCRI BRE 43, 20002688
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193037 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:

Breast Cancer

Study placed in the following topic categories:

Docetaxel
Anti-Bacterial Agents
Skin Diseases

Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009