Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer

This study has been completed.

Sponsored by:	Introgen Therapeutics
Information provided by:	Introgen Therapeutics
ClinicalTrials.gov Identifier:	NCT00286247

Purpose

A maximum of 60 subjects will be enrolled in the trial. It is a non-randomized, open label, single center study. All subjects undergo INGN 201 injection and IV chemotherapy: doxorubicin and docetaxel. This is done on the first 2 days of a 3-week cycle. After completion of 4 to 6 cycles, the subject either proceeds to surgery if the tumors respond to therapy, or goes off study if there is no tumor response.

Condition	Intervention	Phase
Locally Advanced Breast Cancer (LABC)	Genetic: INGN 201	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Docetaxel

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study

Further study details as provided by Introgen Therapeutics:

Estimated Enrollment:

Eligibility

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

Criteria

Documented late stage breast cancer: stage III A-B (excluding inflammatory breast carcinoma) or localized stage IV breast cancer

Male or female

18 years or older

Adequate bone marrow, liver, and kidney function

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00286247

Locations

United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030

Sponsors and Collaborators

Introgen Therapeutics

More Information

Study ID Numbers:	INT 201-010, MDACC ID-00-008
Study First Received:	February 1, 2006
Last Updated:	March 28, 2008
ClinicalTrials.gov Identifier:	NCT00286247
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Docetaxel
Skin Diseases
Breast Neoplasms
Doxorubicin
Breast Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on January 16, 2009