Doxorubicin and Docetaxel in Treating Women With Stage III Breast Cancer - Full Text View

Sponsor:	H. Lee Moffitt Cancer Center and Research Institute
Collaborator:	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	Biological: filgrastim Drug: docetaxel Drug: doxorubicin hydrochloride Procedure: conventional surgery	Phase II

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

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Docetaxel Filgrastim

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Study Start Date:

July 2000

Detailed Description:

OBJECTIVES:

Evaluate the clinical and pathological response rate of sequential doxorubicin and docetaxel chemotherapy in the neoadjuvant treatment of women with stage III breast cancer.
Measure signal transducer and activator of transcription (STAT) activation before and after this neoadjuvant chemotherapy regimen in this patient population.
Correlate response to chemotherapy with STAT activation before and after this neoadjuvant chemotherapy regimen in these patients.
Determine how other potential predictors of response correlate with STAT activation by measuring Bcl-2, Bcl-xL, Bax protein levels, tyrosine kinase levels, growth rate of the tumor, and apoptotic index before and after this neoadjuvant chemotherapy regimen in these patients.
Correlate response to chemotherapy with levels of STAT activation in association with the presence of Bcl-2 proteins and tyrosine kinases, growth rate of the tumor, and apoptotic index in these patients.
Evaluate the toxicity of this neoadjuvant chemotherapy regimen given in a dose-dense fashion in these patients.

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

Criteria

DISEASE CHARACTERISTICS:

Histologically or pathologically confirmed stage III breast cancer
- Clinical evidence of primary invasive breast tumor greater than 5 cm in dimension (T3) and no evidence of metastatic disease clinically or by staging studies including CT scan of the chest, abdomen, and pelvis, and a bone scan
Inflammatory breast carcinoma defined as diffuse brawny induration of the skin of the breast with an erysipeloid edge due to embolization of the dermal lymphatics and pathologic evidence of dermal lymphatic invasion
No bilateral breast cancer unless synchronous
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age:

18 to 70

Sex:

Female

Menopausal status:

Not specified

Performance status:

ECOG 0-1

Life expectancy:

Not specified

Hematopoietic:

WBC at least 3,000/mm^3
Absolute neutrophil count at least 1,000/mm^3
Platelet count at least 100,000/mm^3

Hepatic:

Bilirubin less than 2.0 mg/dL
SGOT/SGPT less than 1.5 times upper limit of normal (ULN)
Alkaline phosphatase no greater than 4 times ULN provided SGOT/SGPT no greater than ULN

Renal:

Creatinine no greater than 1.5 mg/dL

Cardiovascular:

If prior cardiac event or ischemia on electrocardiogram, must be cleared by cardiologist
LVEF at least 50% by resting MUGA
No severe cardiac dysfunction
No prior or concurrent angina pectoris, congestive heart failure, or major ventricular arrhythmias
No uncontrolled essential hypertension

Other:

Not pregnant or nursing
Fertile patients must use effective nonhormonal barrier contraception
No other prior malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma in situ of the breast
No other serious medical or psychiatric illness that would preclude study consent or treatment
No prior severe and intolerable reactions to filgrastim (G-CSF)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

No prior chemotherapy

Endocrine therapy:

Not specified

Radiotherapy:

No prior radiotherapy to the breast

Surgery:

Not specified

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00005800

Locations

United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Susan Minton, DO

H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000067771, MCC-11971, MCC-IRB-5292, NCI-G00-1763
Study First Received:	June 2, 2000
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00005800 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage IIIA breast cancer
stage IIIB breast cancer
inflammatory breast cancer

Additional relevant MeSH terms:

Docetaxel
Neoplasms
Neoplasms by Site
Skin Diseases
Antineoplastic Agents
Therapeutic Uses

Breast Neoplasms
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009