inhaled doxorubicin in treating patients with primary lung cancer or lung metastases

Conditions: Lung Cancer; Metastatic Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. purpose: phase i trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.

objectives: * determine the maximum tolerated dose and phase ii dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung. * determine the toxic effects and pharmacokinetic profile of this regimen in this patient population. * examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. * obtain preliminary evidence of therapeutic activity of this regimen in these patients. outline: this is a dose-escalation study. patients receive inhaled doxorubicin every 3 weeks. treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. patients may reenter at a higher dose level after a 3-month waiting period. 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 6 weeks. projected accrual: a total of 3-36 patients will be accrued for this study.

Eligibility criteria:
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

Keywords: recurrent non-small cell lung cancer extensive stage small cell lung cancer recurrent small cell lung cancer stage iiib non-small cell lung cancer stage iv non-small cell lung cancer lung metastases bronchoalveolar cell lung cancer