SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
Breast Cancer
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, recurrent breast cancer, stage IIIB breast cancer, inflammatory breast cancer, male breast cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically or cytologically confirmed stage IIIB or IV (supraclavicular lymph node involvement or metastasis) inflammatory breast cancer Primary or secondary No brain metastases or primary brain tumors Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: ECOG 0-2 Life expectancy: At least 12 weeks Hematopoietic: WBC at least 3,500/mm^3 Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin greater than 9.0 g/dL Hepatic: Bilirubin normal AST and ALT less than 2 times upper limit of normal PT and PTT normal OR INR less than 1.1 Renal: Creatinine less than 1.5 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular: LVEF at least 50% by MUGA No New York Heart Association class III or IV heart disease No uncompensated coronary artery disease No myocardial infarction or unstable angina within the past 6 months No deep venous or arterial thrombosis within the past 3 months Pulmonary: No history of pulmonary embolism within the past 3 months Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No history of diabetes mellitus with severe peripheral vascular disease No other prior or concurrent malignancies within the past 10 years except inactive nonmelanomatous skin cancer or carcinoma in situ of the cervix No other uncontrolled illnesses PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent epoetin alfa or filgrastim (G-CSF) Chemotherapy: No more than 2 prior chemotherapy regimens allowed No prior doxorubicin or other anthracycline Endocrine therapy: Not specified Radiotherapy: Prior radiotherapy allowed Surgery: Not specified
Sites / Locations
- Ireland Cancer Center at University Hospitals Case Medical Center