Back to resultsComparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Primary Purpose
Breast Neoplasm
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Taxol
TOCOSOL Paclitaxel
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasm focused on measuring Metastatic Breast Cancer
Eligibility Criteria
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
Sites / Locations
- Alta Bates Comprehensive Cancer Center
- Desert Hematology Oncology Medical Group
- Stockton Hematology Oncology
- Florida Cancer Specialists
- Mountain State Tumor Institute
- Southfield Oncology Institute, Inc
- Oncology Care Associates
- Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
- Essex Oncology of North Jersey
- Mid Dakota Clinic
- Hematology Oncology Consultants, Inc
- Chattanooga Oncology & Hematology Associates, PC
- The Sarah Cannon Research Institute
- Joe Arrington Cancer Research and Treatment Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Taxol
TOCOSOL
Arm Description
Taxol 80mg/m2/week
TOCOSOL Paclitaxel
Outcomes
Primary Outcome Measures
Objective response rates
Toxicities
Secondary Outcome Measures
Median overall survival
Progression-free survival
Time-to-disease progression
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00251095
Brief Title
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Terminated
Why Stopped
Failed primary endpoint
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
September 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Achieve Life Sciences
4. Oversight
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasm
Keywords
Metastatic Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
821 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Taxol
Arm Type
Active Comparator
Arm Description
Taxol 80mg/m2/week
Arm Title
TOCOSOL
Arm Type
Experimental
Arm Description
TOCOSOL Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Taxol
Intervention Type
Drug
Intervention Name(s)
TOCOSOL Paclitaxel
Intervention Description
100 mg/m2/week
Primary Outcome Measure Information:
Title
Objective response rates
Time Frame
Based on enrollment
Title
Toxicities
Time Frame
Based on enrollment
Secondary Outcome Measure Information:
Title
Median overall survival
Time Frame
Based on enrollment
Title
Progression-free survival
Time Frame
Based on enrollment
Title
Time-to-disease progression
Time Frame
Based on enrollment
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alta Bates Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Desert Hematology Oncology Medical Group
City
Rancho Mirage
State/Province
California
ZIP/Postal Code
92270
Country
United States
Facility Name
Stockton Hematology Oncology
City
Stockton
State/Province
California
ZIP/Postal Code
95204
Country
United States
Facility Name
Florida Cancer Specialists
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
Mountain State Tumor Institute
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Facility Name
Southfield Oncology Institute, Inc
City
Southfield
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Facility Name
Oncology Care Associates
City
St Joseph
State/Province
Michigan
ZIP/Postal Code
49085
Country
United States
Facility Name
Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Essex Oncology of North Jersey
City
Belleville
State/Province
New Jersey
ZIP/Postal Code
07109
Country
United States
Facility Name
Mid Dakota Clinic
City
Bismarck
State/Province
North Dakota
ZIP/Postal Code
58501
Country
United States
Facility Name
Hematology Oncology Consultants, Inc
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Facility Name
Chattanooga Oncology & Hematology Associates, PC
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
The Sarah Cannon Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Joe Arrington Cancer Research and Treatment Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
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