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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00193037
• Other study ID #: SCRI BRE 43
• Status: Completed
• Phase: Phase 2
• First received: September 12, 2005
• Last updated: July 24, 2013
• Start date: February 2001
• Est. completion date: November 2009

Study information

• Verified date: July 2013
• Source: SCRI Development Innovations, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Liposomal Doxorubicin
Liposomal Doxorubicin
• Docetaxel
Docetaxel

Locations

Country	Name	City	State
United States	Tennessee Oncology	Nashville	Tennessee

Sponsors (3)

Lead Sponsor	Collaborator
SCRI Development Innovations, LLC	Aventis Pharmaceuticals, Ortho Biotech, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	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.	18 Months	No
Secondary	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.	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.	18 Months	No