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| Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00005800 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of doxorubicin and docetaxel in treating women who have stage III breast cancer.
| Condition | Intervention | Phase |
|
Breast Cancer |
Drug: docetaxel Drug: doxorubicin hydrochloride Drug: filgrastim Procedure: conventional surgery |
Phase II |
| Genetics Home Reference related topics: | breast cancer |
| MedlinePlus related topics: | Breast Cancer Cancer |
| Drug Information available for: | Doxorubicin Doxorubicin hydrochloride Filgrastim Docetaxel |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | A Phase II Neoadjuvant Trial of Sequential Doxorubicin and Docetaxel for the Treatment of Stage III Breast Cancer Measuring STAT Activation as a Predictor of Response to Therapy |
| Study Start Date: | July 2000 |
OBJECTIVES:
OUTLINE: Patients receive doxorubicin IV on day 1 every 2 weeks for 3 courses. After 3 weeks of rest, patients receive docetaxel IV over 1 hour on day 1 every 2 weeks for 3 courses. Filgrastim (G-CSF) is administered subcutaneously on days 3-10 of each doxorubicin and docetaxel course. Within 6 weeks of completion of neoadjuvant chemotherapy, patients undergo surgery with mastectomy or lumpectomy and axillary lymph node dissection.
PROJECTED ACCRUAL: A total of 45 patients will be accrued for this study within 5 years.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically or pathologically confirmed stage III breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Contacts and Locations| United States, Florida | |||||
| H. Lee Moffitt Cancer Center and Research Institute | |||||
| Tampa, Florida, United States, 33612-9497 | |||||
| H. Lee Moffitt Cancer Center and Research Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Susan Minton, DO | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000067771, MCC-11971, MCC-IRB-5292, NCI-G00-1763 |
| First Received: | June 2, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00005800 |
| Health Authority: | United States: Federal Government |
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