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

November 8, 2005
June 2, 2009
September 2005
September 2007   (final data collection date for primary outcome measure)
  • Objective response rates [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]
  • Toxicities [ Time Frame: Based on enrollment ] [ Designated as safety issue: Yes ]
  • Objective response rates
  • Toxicities
Complete list of historical versions of study NCT00251095 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Median overall survival
  • Progression-free survival
  • Time-to-disease progression
Not Provided
Not Provided
 
Comparison of Safety and Efficacy of TOCOSOL(R) Paclitaxel Versus Taxol(R) for Treatment of Metastatic Breast Cancer
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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Neoplasm
  • Drug: Taxol
  • Drug: TOCOSOL Paclitaxel
    100 mg/m2/week
  • Active Comparator: Taxol
    Taxol 80mg/m2/week
    Intervention: Drug: Taxol
  • Experimental: TOCOSOL
    TOCOSOL Paclitaxel
    Intervention: Drug: TOCOSOL Paclitaxel
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
821
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00251095
SON-8184-1075
Not Provided
Monica S. Krieger, VP Regulatory Affairs, OncoGenex Pharmaceuticals
OncoGenex Pharmaceuticals
Not Provided
Not Provided
OncoGenex Pharmaceuticals
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP