Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Taxol Taxol 80mg/m2/week |
Drug: Taxol
|
| Experimental: TOCOSOL TOCOSOL Paclitaxel |
Drug: TOCOSOL Paclitaxel
100 mg/m2/week
|
Outcome Measures
Primary Outcome Measures
- Objective response rates [Based on enrollment]
- Toxicities [Based on enrollment]
Secondary Outcome Measures
- Median overall survival [Based on enrollment]
- Progression-free survival [Based on enrollment]
- Time-to-disease progression [Based on enrollment]
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alta Bates Comprehensive Cancer Center | Berkeley | California | United States | 94704 |
| 2 | Desert Hematology Oncology Medical Group | Rancho Mirage | California | United States | 92270 |
| 3 | Stockton Hematology Oncology | Stockton | California | United States | 95204 |
| 4 | Florida Cancer Specialists | Fort Myers | Florida | United States | 33901 |
| 5 | Mountain State Tumor Institute | Boise | Idaho | United States | 83712 |
| 6 | Southfield Oncology Institute, Inc | Southfield | Michigan | United States | 48076 |
| 7 | Oncology Care Associates | St Joseph | Michigan | United States | 49085 |
| 8 | Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | United States | 03756 |
| 9 | Essex Oncology of North Jersey | Belleville | New Jersey | United States | 07109 |
| 10 | Mid Dakota Clinic | Bismarck | North Dakota | United States | 58501 |
| 11 | Hematology Oncology Consultants, Inc | Columbus | Ohio | United States | 43235 |
| 12 | Chattanooga Oncology & Hematology Associates, PC | Chattanooga | Tennessee | United States | 37404 |
| 13 | The Sarah Cannon Research Institute | Nashville | Tennessee | United States | 37203 |
| 14 | Joe Arrington Cancer Research and Treatment Center | Lubbock | Texas | United States | 79410 |
Sponsors and Collaborators
- Achieve Life Sciences
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SON-8184-1075