Lung Cancer, Malignant Mesothelioma, Metastatic Cancer
Conditions
Keywords
recurrent non-small cell lung cancer, extensive stage small cell lung cancer, recurrent small cell lung cancer, advanced malignant mesothelioma, recurrent malignant mesothelioma, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, pulmonary carcinoid tumor, lung metastases
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Giving drugs in different ways may kill more tumor cells. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs.
Detailed description
OBJECTIVES: * Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs. * Determine the toxicity of this regimen in these patients. * Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients. * Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses. Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity. Cohorts of 3-6 patients receive escalating doses of doxorubicin until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed at 3 weeks and 3 months. PROJECTED ACCRUAL: Approximately 33 patients will be accrued for this study within 18-24 months.
Interventions
DRUGdoxorubicin hydrochloride
Sponsors
National Cancer Institute (NCI)
National Institutes of Health Clinical Center (CC)
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
DISEASE CHARACTERISTICS: * Histologically proven advanced cancer not curable by standard chemotherapy, radiotherapy, or surgery * Clinical evidence of primary lung or tracheal cancer OR * Metastatic cancer to the lung * Extrathoracic metastases eligible if following criteria are met: * Sites are stable * Pulmonary sites are primary life-threatening sites * Evidence that study treatment may benefit the patient * Measurable or evaluable disease * No germ cell tumor, leukemia, or lymphoma involving the lungs that is treatable with systemic agents * No complete atelectasis due to high-grade airway obstruction PATIENT CHARACTERISTICS: Age: * 18 and over Performance status: * ECOG 0-1 Life expectancy: * More than 3 months Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Hemoglobin at least 10 g/dL Hepatic: * Bilirubin no greater than 1.0 mg/dL * AST and ALT less than 1.5 times upper limit of normal Renal: * Creatinine no greater than 1.6 mg/dL OR * Creatinine clearance at least 60 mL/min Cardiovascular: * LVEF at least 40% by MUGA scan or echocardiogram * No unstable angina, congestive heart failure, or symptomatic arrhythmias Pulmonary: * DLCO at least 50% predicted * FVC and FEV1 at least 50% predicted * Resting oxygen saturation at least 90% * Exercise oxygen saturation at least 85% * Oxygen consumption greater than 50% predicted * No prior radiation pneumonitis * No asthma * No radiation-induced pulmonary damage Other: * No hypersensitivity to doxorubicin * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception during and for 6 months after study * HIV negative * No congenital problems (e.g., cleft palate) or other anomalies that prevent tight fit of a mouthseal PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior biologic therapy and recovered * No prior trastuzumab (Herceptin) Chemotherapy: * See Disease Characteristics * At least 4 weeks since prior chemotherapy and recovered * Prior doxorubicin allowed if LVEF at least 40% by MUGA scan or echocardiogram * No prior mitomycin, bleomycin, or nitrosoureas * No other concurrent systemic chemotherapy Endocrine therapy: * Not specified Radiotherapy: * See Disease Characteristics * At least 4 weeks since prior radiotherapy and recovered * At least 12 months since prior radiotherapy to chest * No prior radiotherapy to more than 20% of total lung volume * Prior chest wall or primary breast radiotherapy allowed * Prior radioactive iodine allowed * No concurrent thoracic radiotherapy Surgery: * See Disease Characteristics * No prior total pneumonectomy Other: * No other concurrent experimental drug
Countries
United States
Outcome results
None listed