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

NCT ID: NCT00251095

Last Updated: 2009-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

821 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2007-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Breast Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Taxol

Taxol 80mg/m2/week

Group Type ACTIVE_COMPARATOR

Taxol

Intervention Type DRUG

TOCOSOL

TOCOSOL Paclitaxel

Group Type EXPERIMENTAL

TOCOSOL Paclitaxel

Intervention Type DRUG

100 mg/m2/week

Interventions

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Taxol

Intervention Type DRUG

TOCOSOL Paclitaxel

100 mg/m2/week

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Achieve Life Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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OncoGenex Pharmaceuticals

Locations

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Alta Bates Comprehensive Cancer Center

Berkeley, California, United States

Site Status

Desert Hematology Oncology Medical Group

Rancho Mirage, California, United States

Site Status

Stockton Hematology Oncology

Stockton, California, United States

Site Status

Florida Cancer Specialists

Fort Myers, Florida, United States

Site Status

Mountain State Tumor Institute

Boise, Idaho, United States

Site Status

Oncology Care Associates

Saint Joseph, Michigan, United States

Site Status

Southfield Oncology Institute, Inc

Southfield, Michigan, United States

Site Status

Norris Cotton Cancer Center, Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Essex Oncology of North Jersey

Belleville, New Jersey, United States

Site Status

Mid Dakota Clinic

Bismarck, North Dakota, United States

Site Status

Hematology Oncology Consultants, Inc

Columbus, Ohio, United States

Site Status

Chattanooga Oncology & Hematology Associates, PC

Chattanooga, Tennessee, United States

Site Status

The Sarah Cannon Research Institute

Nashville, Tennessee, United States

Site Status

Joe Arrington Cancer Research and Treatment Center

Lubbock, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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SON-8184-1075

Identifier Type: -

Identifier Source: org_study_id

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