Expired Study
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Nashville, Tennessee 37203


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.


Study summary:

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.


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.


Study is Available At:


Original ID:

SCRI BRE 43


NCT ID:

NCT00193037


Secondary ID:

20002688


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Sarah Cannon Research Institute


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

120


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Denise A. Yardley, MD
Principal Investigator
Sarah Cannon Research Institute

Study Dates

Start Date:February 2001
Completion Date:November 2009
Completion Type:Actual
Primary Completion Date:December 2008
Primary Completion Type:Actual
Verification Date:May 2011
Last Changed Date:May 2, 2011
First Received Date:September 12, 2005

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Time to progression
Time Frame:18 Months
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Overall survival
Time Frame:18 Months
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:Liposomal Doxorubicin
Description:Liposomal Doxorubicin
Intervention Type:Drug
Name:Docetaxel
Description:Docetaxel

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Sarah Cannon Research Institute
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Ortho Biotech, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

Reference Type:Results Reference
Citation: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.
PMID:19933081

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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