Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV 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. Identifier: NCT00044993
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : May 30, 2013
Information provided by:
National Cancer Institute (NCI)

September 6, 2002
January 27, 2003
May 30, 2013
February 2002
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Complete list of historical versions of study NCT00044993 on Archive Site
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Chemotherapy Combined With Gene Therapy in Treating Patients Who Have Stage III or Stage IV Breast Cancer
Phase II, Single Arm, Single Institution Clinical Trial of Docetaxel and Doxorubicin in Combination With Local Administration of INGN 201 (Ad5CMV-p53) in Locally Advanced Breast Cancer (LABC)

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Inserting the p53 gene into the tumor may increase the effectiveness of a chemotherapy drug by making tumor cells more sensitive to the drug. Combining chemotherapy with gene therapy may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining chemotherapy with gene therapy in treating patients who have stage III or stage IV breast cancer.


  • Determine the therapeutic efficacy of docetaxel, doxorubicin, and Ad5CMV-p53 gene in patients with locally advanced breast cancer.

OUTLINE: Patients receive p53 gene by intralesional injection on days 1 and 2. Patients also receive doxorubicin IV over 15 minutes followed 1 hour later by docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 6 courses. After completion of chemotherapy, patients with a reasonable response undergo surgical resection.

PROJECTED ACCRUAL: A maximum of 60 patients will be accrued for this study.

Phase 2
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Cancer
  • Biological: Ad5CMV-p53 gene
  • Drug: docetaxel
  • Drug: doxorubicin hydrochloride
  • Procedure: conventional surgery
  • Procedure: neoadjuvant therapy
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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August 2004
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  • Histologically confirmed breast cancer

    • Stage IIIA, IIIB (excluding inflammatory breast carcinoma), or IIIC OR
    • Localized stage IV
  • Measurable disease
  • No metastases
  • Hormone receptor status:

    • Not specified



  • 18 and over


  • Male or female

Menopausal status

  • Not specified

Performance status

  • Karnofsky 70-100%

Life expectancy

  • Not specified


  • Adequate bone marrow function


  • Adequate liver function
  • Hepatitis B surface antigen negative
  • Hepatitis C antibody negative


  • Adequate kidney function


  • Normal cardiac function by MUGA and/or echocardiogram


  • No psychological, familial, sociological, or geographical conditions that would preclude study
  • Not pregnant or nursing
  • Fertile patients must use effective barrier method of contraception


Biologic therapy

  • No prior gene therapy using adenoviral vectors or p53 gene product


  • No prior chemotherapy for breast cancer

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000256223 ( Registry Identifier: PDQ (Physician Data Query) )
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Introgen Therapeutics
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Study Chair: Jill Van Warthood, PhD Introgen Therapeutics
National Cancer Institute (NCI)
July 2004

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP