Clinical trial NCT00251095: 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
Overall status: TERMINATED
Phase: PHASE3
Conditions: Breast Neoplasm
Keywords: Metastatic Breast Cancer
Lead sponsor: Achieve Life Sciences
Sponsor class: INDUSTRY
First posted: 2005-11-09
Enrollment: 821
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Objective response rates
timeFrame: Based on enrollment
measure: Toxicities
timeFrame: Based on enrollment
Secondary outcomes:
measure: Median overall survival
timeFrame: Based on enrollment
measure: Progression-free survival
timeFrame: Based on enrollment
measure: Time-to-disease progression
timeFrame: Based on enrollment
Other outcomes:
Locations:
city: Berkeley
country: United States
facility: Alta Bates Comprehensive Cancer Center
state: California
city: Rancho Mirage
country: United States
facility: Desert Hematology Oncology Medical Group
state: California
city: Stockton
country: United States
facility: Stockton Hematology Oncology
state: California
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Boise
country: United States
facility: Mountain State Tumor Institute
state: Idaho
city: Southfield
country: United States
facility: Southfield Oncology Institute, Inc
state: Michigan
city: St Joseph
country: United States
facility: Oncology Care Associates
state: Michigan
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
state: New Hampshire
city: Belleville
country: United States
facility: Essex Oncology of North Jersey
state: New Jersey
city: Bismarck
country: United States
facility: Mid Dakota Clinic
state: North Dakota
city: Columbus
country: United States
facility: Hematology Oncology Consultants, Inc
state: Ohio
city: Chattanooga
country: United States
facility: Chattanooga Oncology & Hematology Associates, PC
state: Tennessee
city: Nashville
country: United States
facility: The Sarah Cannon Research Institute
state: Tennessee
city: Lubbock
country: United States
facility: Joe Arrington Cancer Research and Treatment Center
state: Texas
Study officials:
References: