NCT00251095

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
821

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2005

Geographic Reach
1 country

14 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 9, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

June 4, 2009

Status Verified

June 1, 2009

Enrollment Period

2 years

First QC Date

November 8, 2005

Last Update Submit

June 2, 2009

Conditions

Breast Neoplasm

Keywords

Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (2)

  • Objective response rates

    Based on enrollment

  • Toxicities

    Based on enrollment

Secondary Outcomes (3)

  • Median overall survival

    Based on enrollment

  • Progression-free survival

    Based on enrollment

  • Time-to-disease progression

    Based on enrollment

Study Arms (2)

Taxol

ACTIVE COMPARATOR

Taxol 80mg/m2/week

Drug: Taxol

TOCOSOL

EXPERIMENTAL

TOCOSOL Paclitaxel

Drug: TOCOSOL Paclitaxel

Interventions

TaxolDRUG
Taxol
TOCOSOL PaclitaxelDRUG

100 mg/m2/week

TOCOSOL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with histologic diagnosis of breast carcinoma
  • Stage IV (M1) disease
  • Adult (18 years of age or older) patients

You may not qualify if:

  • Patients treated with a taxane within the past year
  • Patients whose tumor tissue is known to show over expression of HER2/neu

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Alta Bates Comprehensive Cancer Center

Berkeley, California, 94704, United States

Location

Desert Hematology Oncology Medical Group

Rancho Mirage, California, 92270, United States

Location

Stockton Hematology Oncology

Stockton, California, 95204, United States

Location

Florida Cancer Specialists

Fort Myers, Florida, 33901, United States

Location

Mountain State Tumor Institute

Boise, Idaho, 83712, United States

Location

Oncology Care Associates

Saint Joseph, Michigan, 49085, United States

Location

Southfield Oncology Institute, Inc

Southfield, Michigan, 48076, United States

Location

Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756, United States

Location

Essex Oncology of North Jersey

Belleville, New Jersey, 07109, United States

Location

Mid Dakota Clinic

Bismarck, North Dakota, 58501, United States

Location

Hematology Oncology Consultants, Inc

Columbus, Ohio, 43235, United States

Location

Chattanooga Oncology & Hematology Associates, PC

Chattanooga, Tennessee, 37404, United States

Location

The Sarah Cannon Research Institute

Nashville, Tennessee, 37203, United States

Location

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, 79410, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 8, 2005

First Posted

November 9, 2005

Study Start

September 1, 2005

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 4, 2009

Record last verified: 2009-06

Locations

US(14)