Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
June 2, 2009 updated by: Achieve Life Sciences
A Multicenter Phase 3, Randomized Comparison of the Safety and Efficacy of Weekly TOCOSOL(R) Paclitaxel vs. Weekly Paclitaxel Injection in the Treatment of Metastatic Breast Cancer
The purpose of this study is to compare the objective response rates of patients randomized to receive either TOCOSOL(R) Paclitaxel or Taxol(R) (paclitaxel injection) administered every week to patients with metastatic breast cancer.
The study hypothesis is that the objective response rate with TOCOSOL Paclitaxel given every week is non-inferior to that observed with Taxol given every week.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Detailed Description
Female patients with first or second line metastatic breast cancer will be randomized to receive either weekly TOCOSOL Paclitaxel or weekly Taxol (paclitaxel injection).
Patients will undergo radiographic imaging of their disease to assess response to therapy.
The primary endpoint of this study is a comparison of the objective response rates observed in patients receiving TOCOSOL Paclitaxel, to those receiving Taxol.
Time-to-disease progression and overall survival will also be compared.
The toxicities of the two treatment regimens will be compared.
Study Type
Interventional
Enrollment (Actual)
821
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
California
-
Berkeley, California, United States, 94704
- Alta Bates Comprehensive Cancer Center
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Rancho Mirage, California, United States, 92270
- Desert Hematology Oncology Medical Group
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Stockton, California, United States, 95204
- Stockton Hematology Oncology
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-
Florida
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Fort Myers, Florida, United States, 33901
- Florida Cancer Specialists
-
-
Idaho
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Boise, Idaho, United States, 83712
- Mountain State Tumor Institute
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-
Michigan
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Southfield, Michigan, United States, 48076
- Southfield Oncology Institute, Inc
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St Joseph, Michigan, United States, 49085
- Oncology Care Associates
-
-
New Hampshire
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Lebanon, New Hampshire, United States, 03756
- Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
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-
New Jersey
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Belleville, New Jersey, United States, 07109
- Essex Oncology of North Jersey
-
-
North Dakota
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Bismarck, North Dakota, United States, 58501
- Mid Dakota Clinic
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-
Ohio
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Columbus, Ohio, United States, 43235
- Hematology Oncology Consultants, Inc
-
-
Tennessee
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Chattanooga, Tennessee, United States, 37404
- Chattanooga Oncology & Hematology Associates, PC
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Nashville, Tennessee, United States, 37203
- The Sarah Cannon Research Institute
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Texas
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Lubbock, Texas, United States, 79410
- Joe Arrington Cancer Research and Treatment Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Patients with histologic diagnosis of breast carcinoma
- Stage IV (M1) disease
- Adult (18 years of age or older) patients
Exclusion Criteria:
- Patients treated with a taxane within the past year
- Patients whose tumor tissue is known to show over expression of HER2/neu
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Taxol
Taxol 80mg/m2/week
|
|
|
Experimental: TOCOSOL
TOCOSOL Paclitaxel
|
100 mg/m2/week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Objective response rates
Time Frame: Based on enrollment
|
Based on enrollment
|
|
Toxicities
Time Frame: Based on enrollment
|
Based on enrollment
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Median overall survival
Time Frame: Based on enrollment
|
Based on enrollment
|
|
Progression-free survival
Time Frame: Based on enrollment
|
Based on enrollment
|
|
Time-to-disease progression
Time Frame: Based on enrollment
|
Based on enrollment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2005
Primary Completion (Actual)
September 1, 2007
Study Completion (Actual)
September 1, 2007
Study Registration Dates
First Submitted
November 8, 2005
First Submitted That Met QC Criteria
November 8, 2005
First Posted (Estimate)
November 9, 2005
Study Record Updates
Last Update Posted (Estimate)
June 4, 2009
Last Update Submitted That Met QC Criteria
June 2, 2009
Last Verified
June 1, 2009
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SON-8184-1075
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.