Overview

Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer

Status:
Completed

Trial end date:
2005-06-01

Target enrollment:
0

Participant gender:
Female

Summary

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 combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.

Phase:

Phase 2

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwestern University

Collaborator:

National Cancer Institute (NCI)

Treatments:

Cyclophosphamide
Docetaxel
Doxorubicin
Liposomal doxorubicin

Criteria

DISEASE CHARACTERISTICS: Histologically or cytologically confirmed previously untreated,
stage III adenocarcinoma of the breast At least one bidimensionally and/or unidimensionally
measurable lesion No evidence of disease outside the breast or chest wall, except for
ipsilateral axillary lymph nodes Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic:
Neutrophil count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin
no greater than upper limit of normal (ULN) SGOT no greater than 3 times ULN Alkaline
phosphatase no greater than 5 times ULN No acute hepatitis Renal: Creatinine no greater
than 1.5 mg/dL No uncontrolled hypercalcemia Cardiovascular: No congestive heart failure
LVEF normal No angina pectoris No uncontrolled cardiac arrhythmias No other significant
heart disease No myocardial infarction within the past year No superior vena cava syndrome
No deep vein thrombosis requiring anticoagulant therapy Neurologic: No dementia No seizures
No concurrent grade 2 or greater peripheral neuropathy Other: No medical instability No
active infection No gastrointestinal bleeding No uncontrolled diabetes No psychological,
familial, sociological, or geographical conditions or other circumstances that would
preclude study No other malignancy within the past 5 years except curatively treated basal
cell skin cancer or carcinoma in situ of the cervix No history of hypersensitivity to
polysorbate 80 Not pregnant or nursing Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No prior immunotherapy for breast cancer
Chemotherapy: No prior chemotherapy for breast cancer Endocrine therapy: No prior hormonal
therapy for breast cancer No concurrent corticosteroids except for chronic
methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day
Radiotherapy: Not specified Surgery: Not specified Other: At least 3 weeks since prior
investigational drugs