Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

Criterios de inclusión

• Cardiovascular:
• DISEASE CHARACTERISTICS:
• Histologically confirmed metastatic breast cancer
• Bidimensionally measurable lesions
• The following are not considered measurable:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
• No CNS metastases
• Hormone receptor status:
• Not specified
• PATIENT CHARACTERISTICS:
• Age:
• to 75
• Sex:
• Female
• Menopausal status:
• Not specified
• Performance status:
• ECOG 0-2 OR
• Zubrod 0-2
• Life expectancy:
• More than 12 weeks
• Hematopoietic:
• WBC at least 4,000/mm\^3
• Platelet count at least 100,000/mm\^3
• Hemoglobin at least 11 g/dL
• Hepatic:
• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• SGOT no greater than 1.25 times ULN
• Renal:
• Creatinine clearance at least 60 mL/min
• No history of congestive heart failure
• No myocardial infarction within the past 6 months
• No active ischemic heart disease
• No uncontrolled hypertension
• Other:
• Not pregnant
• No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
• No other medical or psychiatric diseases that would preclude study
• No geographical situation that would preclude study
• No history of alcohol abuse
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• No prior adjuvant chemotherapy including ifosfamide or docetaxel
• No prior systemic chemotherapy for metastatic breast cancer
• Endocrine therapy:
• See Disease Characteristics
• No concurrent corticoids, gestagens, or androgens unless strictly indicated
• Radiotherapy:
• Not specified
• Surgery:
• Not specified
• Other:
• No concurrent drinks containing caffeine or alcohol