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

  • United States
    • California
      • Berkeley, California, United States, 94704
        • Alta Bates Comprehensive Cancer Center
      • Rancho Mirage, California, United States, 92270
        • Desert Hematology Oncology Medical Group
      • Stockton, California, United States, 95204
        • Stockton Hematology Oncology
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Florida Cancer Specialists
    • Idaho
      • Boise, Idaho, United States, 83712
        • Mountain State Tumor Institute
    • Michigan
      • Southfield, Michigan, United States, 48076
        • Southfield Oncology Institute, Inc
      • St Joseph, Michigan, United States, 49085
        • Oncology Care Associates
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
    • New Jersey
      • Belleville, New Jersey, United States, 07109
        • Essex Oncology of North Jersey
    • North Dakota
      • Bismarck, North Dakota, United States, 58501
        • Mid Dakota Clinic
    • Ohio
      • Columbus, Ohio, United States, 43235
        • Hematology Oncology Consultants, Inc
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • Chattanooga Oncology & Hematology Associates, PC
      • Nashville, Tennessee, United States, 37203
        • The Sarah Cannon Research Institute
    • Texas
      • 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
Drug: Taxol
Experimental: TOCOSOL
TOCOSOL Paclitaxel
Drug: 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

Achieve Life Sciences

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.

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