Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

Fecha de inicio: 1 de julio de 1999

DISEASE CHARACTERISTICS: Histologically confirmed primary lung cancer or cancer metastatic to the lung that is not potentially curable by standard chemotherapy, radiotherapy, or surgery Bronchoalveolar cell lung cancer allowed Lung metastases from soft tissue sarcoma allowed No leukemia or lymphoma PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 70-100% Life expectancy: Not specified Hematopoietic: WBC at least 4,000/mm^3 Platelet count at least 160,000/mm^3 Hemoglobin at least 9 g/dL Hepatic: Bilirubin no greater than 1.0 mg/dL AST/ALT less than 1.5 times upper limit of normal Renal: Creatinine no greater than 1.2 mg/dL OR Creatinine clearance at least 50 mL/min Cardiovascular: LVEF normal by MUGA scan or echocardiography No unstable angina No congestive heart failure No symptomatic arrhythmias Pulmonary: DLCO at least 65% of normal FVC at least 50% predicted FEV1 at least 50% predicted Resting oxygen saturation at least 90% Exercise oxygen saturation at least 85% No complete atelectasis No asthma Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after study No congenital problems (e.g., cleft palate) or other anomalies that would prevent tight fit of mouth seal No other concurrent illness that would preclude study therapy PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy and recovered No prior bleomycin or nitrosoureas No prior mitomycin greater than 25 mg/m^2 No prior anthracyclines greater than 450 mg/m^2 No other concurrent chemotherapy Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy and recovered No prior chest (pulmonary or mediastinal) or thoracic spine radiotherapy Patients with only chest wall or primary breast radiation are eligible No concurrent thoracic irradiation Surgery: See Disease Characteristics No prior pneumonectomy Other: No daily or as necessary respiratory drugs via inhaler or nebulizer No other concurrent experimental drugs