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)
18 Years
N/A
Both
Breast Cancer
Trial Information
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)
OBJECTIVES:
- 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.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- 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
PATIENT CHARACTERISTICS:
Age
- 18 and over
Sex
- Male or female
Menopausal status
- Not specified
Performance status
- Karnofsky 70-100%
Life expectancy
- Not specified
Hematopoietic
- Adequate bone marrow function
Hepatic
- Adequate liver function
- Hepatitis B surface antigen negative
- Hepatitis C antibody negative
Renal
- Adequate kidney function
Cardiovascular
- Normal cardiac function by MUGA and/or echocardiogram
Other
- No psychological, familial, sociological, or geographical conditions that would
preclude study
- Not pregnant or nursing
- Fertile patients must use effective barrier method of contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior gene therapy using adenoviral vectors or p53 gene product
Chemotherapy
- No prior chemotherapy for breast cancer
Endocrine therapy
- Not specified
Radiotherapy
- Not specified
Surgery
- Not specified
Type of Study:
Interventional
Study Design:
Masking: Open Label, Primary Purpose: Treatment
Principal Investigator
Jill Van Warthood, PhD
Investigator Role:
Study Chair
Investigator Affiliation:
Introgen Therapeutics
Authority:
United States: Federal Government
Study ID:
INTROGEN-201-010
NCT ID:
NCT00044993
Start Date:
February 2002
Completion Date:
August 2004
Related Keywords:
- Breast Cancer
- male breast cancer
- stage IIIA breast cancer
- stage IIIB breast cancer
- stage IIIC breast cancer
- stage IV breast cancer
- Breast Neoplasms
Name | Location |
|---|---|
| University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
