Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Lung Cancer, Malignant Mesothelioma, Metastatic Cancer

Intervention / Treatment
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* Drug: doxorubicin hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: doxorubicin hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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