Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer

Breast Neoplasm Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00251095
• Other study ID #: SON-8184-1075
• Status: Terminated
• Phase: Phase 3
• First received: November 8, 2005
• Last updated: June 2, 2009
• Start date: September 2005
• Est. completion date: September 2007

Study information

• Verified date: June 2009
• Source: OncoGenex Technologies
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 821
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Breast Neoplasm
• Breast Neoplasms

Intervention

Drug:
• Taxol

• TOCOSOL Paclitaxel
100 mg/m2/week

Locations

Country	Name	City	State
United States	Essex Oncology of North Jersey	Belleville	New Jersey
United States	Alta Bates Comprehensive Cancer Center	Berkeley	California
United States	Mid Dakota Clinic	Bismarck	North Dakota
United States	Mountain State Tumor Institute	Boise	Idaho
United States	Chattanooga Oncology & Hematology Associates, PC	Chattanooga	Tennessee
United States	Hematology Oncology Consultants, Inc	Columbus	Ohio
United States	Florida Cancer Specialists	Fort Myers	Florida
United States	Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Joe Arrington Cancer Research and Treatment Center	Lubbock	Texas
United States	The Sarah Cannon Research Institute	Nashville	Tennessee
United States	Desert Hematology Oncology Medical Group	Rancho Mirage	California
United States	Southfield Oncology Institute, Inc	Southfield	Michigan
United States	Oncology Care Associates	St Joseph	Michigan
United States	Stockton Hematology Oncology	Stockton	California

Sponsors (1)

Lead Sponsor	Collaborator
OncoGenex Technologies

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Objective response rates		Based on enrollment	Yes
Primary	Toxicities		Based on enrollment	Yes
Secondary	Median overall survival		Based on enrollment	Yes
Secondary	Progression-free survival		Based on enrollment	Yes
Secondary	Time-to-disease progression		Based on enrollment	No