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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00286247
Recruitment Status : Completed
First Posted : February 3, 2006
Last Update Posted : April 1, 2008
Sponsor:
Information provided by:
Introgen Therapeutics

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Locally Advanced Breast Cancer (LABC) Genetic: INGN 201 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00286247


Locations
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United States, Texas
M.D. Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
Introgen Therapeutics
More Information
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ClinicalTrials.gov Identifier: NCT00286247    
Other Study ID Numbers: INT 201-010
MDACC ID-00-008
First Posted: February 3, 2006    Key Record Dates
Last Update Posted: April 1, 2008
Last Verified: March 2008
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases