A Phase I-II Trial of Mild Whole-Body Hyperthermia Combined With Liposomal Doxorubicin/5-Fluorouracil in Patients With Advanced Malignancy

Fecha de inicio: 1 de noviembre de 1997

DISEASE CHARACTERISTICS: Histologically confirmed metastatic breast, ovarian, endometrial, or cervical carcinoma Measurable and evaluable disease No brain metastases No hepatic involvement greater than 80% No lung involvement greater than 30% Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: 18 and over Sex: Not specified Menopausal status: Not specified Performance status: Zubrod 0-2 Life expectancy: At least 12 weeks Hematopoietic: Absolute granulocyte count greater than 1,500/mm^3 Platelet count greater than 90,000/mm^3 Normal bone marrow cellularity on bone marrow biopsy Thrombin time less than 17 sec Fibrinogen greater than 200 mg/dL FSP less than 40 No coagulopathy Hepatic: Bilirubin less than 2.0 mg/dL SGPT less than 2 times normal PT less than 14 sec PTT less than 35 sec Renal: BUN less than 25 mg/dL Creatinine clearance at least 45 mL/min Cardiovascular: Normal cardiovascular system Resting ventricular ejection fraction greater than 40% No prior myocardial infarction No symptomatic coronary artery disease No unstable blood pressure No thromboembolic disease Neurologic: No seizures or other CNS disorders Negative computerized tomographic scan of brain Pulmonary: FEV_1 greater than 70% of predicted Arterial pressure of oxygen greater than 60 mmHg on room air with appropriate pressure of carbon dioxide and pH values No history of cardiopulmonary or respiratory disease Other: No other serious concurrent medical illness No diabetes mellitus PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Prior chemotherapy allowed Endocrine therapy: No adrenal corticosteroids Radiotherapy: Not specified Surgery: Not specified Other: No concurrent cardiac glycosides, antianginal therapy, or antiarrhythmics No concurrent vasodilators, anticoagulants, thrombolytic agents, or aspirin