Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Information source: SCRI Development Innovations, LLC
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Breast Cancer
Intervention: Liposomal Doxorubicin (Drug); Docetaxel (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: SCRI Development Innovations, LLC Official(s) and/or principal investigator(s): Denise A. Yardley, MD, Principal Investigator, Affiliation: SCRI Development Innovations, LLC
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.
Clinical Details
Official title: A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment
Secondary outcome: 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.
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Tennessee Oncology, Nashville, Tennessee 37203, United States
Additional Information
Published article in Clinical Breast Cancer
Starting date: February 2001
Last updated: July 24, 2013
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