Study to Determine the Efficacy and Safety of Docetaxel and Doxorubicin With INGN 201 in Locally Advanced Breast Cancer
This study has been completed.
Sponsor:
Introgen Therapeutics
Information provided by:
Introgen Therapeutics
ClinicalTrials.gov Identifier:
NCT00286247
First received: February 1, 2006
Last updated: March 28, 2008
Last verified: March 2008
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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 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
Resource links provided by NLM:
Further study details as provided by Introgen Therapeutics:
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 More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00286247 History of Changes |
| Other Study ID Numbers: | INT 201-010, MDACC ID-00-008 |
| Study First Received: | February 1, 2006 |
| Last Updated: | March 28, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on June 13, 2013