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

This study has been terminated.
(Failed primary endpoint)
Sponsor:
Information provided by:
OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00251095
First received: November 8, 2005
Last updated: June 2, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention Phase
Breast Neoplasm
 Drug: Taxol
Drug: TOCOSOL Paclitaxel
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

Drug Information available for: Paclitaxel
U.S. FDA Resources

Further study details as provided by OncoGenex Pharmaceuticals:

Primary Outcome Measures:
  • Objective response rates [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]
  • Toxicities [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Median overall survival [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]
  • Progression-free survival [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]
  • Time-to-disease progression [ Time Frame: Based on enrollment ] [ Designated as safety issue: No ]

Enrollment: 821
Study Start Date: September 2005
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Taxol
Taxol 80mg/m2/week
 Drug: Taxol
Experimental: TOCOSOL
TOCOSOL Paclitaxel
 Drug: TOCOSOL Paclitaxel
100 mg/m2/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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00251095

Locations
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
OncoGenex Pharmaceuticals
  More Information

No publications provided

Responsible Party: Monica S. Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00251095     History of Changes
Other Study ID Numbers: SON-8184-1075
Study First Received: November 8, 2005
Last Updated: June 2, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by OncoGenex Pharmaceuticals:
Metastatic Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Paclitaxel
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013