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

NCT ID: NCT00193037

Last Updated: 2013-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 102 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-02-28
• Study Completion Date: 2009-11-30

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Liposomal Doxorubicin

Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.

Group Type: EXPERIMENTAL

Liposomal Doxorubicin

Intervention Type: DRUG

Liposomal Doxorubicin

Docetaxel

Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle

Group Type: EXPERIMENTAL

Docetaxel

Intervention Type: DRUG

Docetaxel

Interventions

Liposomal Doxorubicin

Liposomal Doxorubicin

Intervention Type: DRUG

Docetaxel

Docetaxel

Intervention Type: DRUG

Other Intervention Names

Doxil; Taxotere

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ortho Biotech, Inc.

INDUSTRY

Sponsor Role: collaborator

Aventis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

SCRI Development Innovations, LLC

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Denise A. Yardley, MD

Role: PRINCIPAL_INVESTIGATOR

SCRI Development Innovations, LLC

Locations

Tennessee Oncology

Nashville, Tennessee, United States

Countries

United States

References

Yardley DA, Burris HA 3rd, Spigel DR, Clark BL, Vazquez E, Shipley D, Barton J, Thompson D, Montes I, Greco FA, Hainsworth JD. A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):247-52. doi: 10.3816/CBC.2009.n.042.

Reference Type: RESULT

PMID: 19933081 (View on PubMed)

Related Links

http://cigjournals.metapress.com/content/h221p3m53r461w57/fulltext.pdf

Published article in Clinical Breast Cancer

Other Identifiers

SCRI BRE 43

Identifier Type: -

Identifier Source: org_study_id