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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00251095
Recruitment Status : Terminated (Failed primary endpoint)
First Posted : November 9, 2005
Last Update Posted : June 4, 2009
Information provided by:
Achieve Life Sciences

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
Breast Neoplasm Drug: Taxol Drug: TOCOSOL Paclitaxel 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 821 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : September 2007
Actual Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Paclitaxel
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Taxol
Taxol 80mg/m2/week
Drug: Taxol
Experimental: TOCOSOL
TOCOSOL Paclitaxel
Drug: TOCOSOL Paclitaxel
100 mg/m2/week

Primary Outcome Measures :
  1. Objective response rates [ Time Frame: Based on enrollment ]
  2. Toxicities [ Time Frame: Based on enrollment ]

Secondary Outcome Measures :
  1. Median overall survival [ Time Frame: Based on enrollment ]
  2. Progression-free survival [ Time Frame: Based on enrollment ]
  3. Time-to-disease progression [ Time Frame: Based on enrollment ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00251095

United States, California
Alta Bates Comprehensive Cancer Center
Berkeley, California, United States, 94704
Desert Hematology Oncology Medical Group
Rancho Mirage, California, United States, 92270
Stockton Hematology Oncology
Stockton, California, United States, 95204
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
United States, Idaho
Mountain State Tumor Institute
Boise, Idaho, United States, 83712
United States, Michigan
Southfield Oncology Institute, Inc
Southfield, Michigan, United States, 48076
Oncology Care Associates
St Joseph, Michigan, United States, 49085
United States, New Hampshire
Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
Essex Oncology of North Jersey
Belleville, New Jersey, United States, 07109
United States, North Dakota
Mid Dakota Clinic
Bismarck, North Dakota, United States, 58501
United States, Ohio
Hematology Oncology Consultants, Inc
Columbus, Ohio, United States, 43235
United States, Tennessee
Chattanooga Oncology & Hematology Associates, PC
Chattanooga, Tennessee, United States, 37404
The Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
United States, Texas
Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, United States, 79410
Sponsors and Collaborators
Achieve Life Sciences

Responsible Party: Monica S. Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals Identifier: NCT00251095     History of Changes
Other Study ID Numbers: SON-8184-1075
First Posted: November 9, 2005    Key Record Dates
Last Update Posted: June 4, 2009
Last Verified: June 2009

Keywords provided by Achieve Life Sciences:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action