Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

This study has been completed.

First Received: September 12, 2005 Last Updated: January 15, 2009 History of Changes

Sponsors and Collaborators:	Sarah Cannon Research Institute SCRI Oncology Research Consortium Novartis Aventis Pharmaceuticals
Information provided by:	Sarah Cannon Research Institute
ClinicalTrials.gov Identifier:	NCT00193180

Purpose

This trial evaluates the novel combination of docetaxel with imatinib as first or second line therapy in advanced breast cancer with the aim of achieving higher effectiveness and potentially reducing side effects.

Condition	Intervention	Phase
Breast Cancer	Drug: Imatinib Drug: Docetaxel	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Docetaxel Imatinib Imatinib mesylate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Trial of Docetaxel Plus Imatinib Mesylate in Metastatic Breast Cancer

Further study details as provided by Sarah Cannon Research Institute:

Primary Outcome Measures:

Overall response rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	40
Study Start Date:	May 2005
Study Completion Date:	January 2009
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Docetaxel + Imatinib	Drug: Imatinib Imatinib Drug: Docetaxel Docetaxel

Detailed Description:

Upon determination of eligibility, patients will be receive:

Docetaxel + Imatinib

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

To be included in this study, you must meet the following criteria:

Metastatic breast cancer confirmed by biopsy
No more than one prior chemotherapy regimen for metastatic breast cancer
Able to perform activities of daily living with minimal assistance
Adequate bone marrow, liver and kidney function
Age 18 years or older
Give written informed consent

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

Moderate to severe peripheral neuropathy
Uncontrolled blood pressure or uncontrolled heart beat irregularities
Diabetes Mellitus with fasting blood sugar greater than 200 mg %
Significant heart disease within the prior 6 months
Severe or uncontrolled medical disease
Active uncontrolled infection
Known chronic liver disease
Known diagnosis of HIV infection
Pregnant or breast feeding females

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00193180

Locations

United States, Georgia
Northeast Georgia Medical Center
Gainesville, Georgia, United States, 30501
United States, Kentucky
Consultants in Blood Disorders and Cancer
Louisville, Kentucky, United States, 40207
United States, Louisiana
Baton Rouge General Medical Center
Baton Rouge, Louisiana, United States, 70806
United States, Nebraska
Methodist Cancer Center
Omaha, Nebraska, United States, 68114
United States, Ohio
Oncology Hematology Care
Cincinnati, Ohio, United States, 45242
United States, Tennessee
Tennessee Oncology
Nashville, Tennessee, United States, 37203

Sponsors and Collaborators

Sarah Cannon Research Institute

SCRI Oncology Research Consortium

Novartis

Aventis Pharmaceuticals

Investigators

Principal Investigator:

Denise A. Yardley, MD

Sarah Cannon Research Institute

More Information

No publications provided

Responsible Party:	SCRI Oncology Research Consortium ( Denise A. Yardley, M.D. )
Study ID Numbers:	SCRI BRE 74, IIT 11259, BUS205
Study First Received:	September 12, 2005
Last Updated:	January 15, 2009
ClinicalTrials.gov Identifier:	NCT00193180 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Sarah Cannon Research Institute:

Breast Cancer

Study placed in the following topic categories:

Imatinib
Docetaxel
Skin Diseases

Breast Neoplasms
Protein Kinase Inhibitors
Breast Diseases

Additional relevant MeSH terms:

Skin Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Breast Neoplasms
Enzyme Inhibitors
Protein Kinase Inhibitors
Pharmacologic Actions

Docetaxel
Imatinib
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on May 07, 2009