Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Lung Cancer Metastatic Cancer

Interventions

doxorubicin hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Arthur G. James Cancer Hospital - Ohio State University

Columbus, Ohio, United States

Data from ClinicalTrials.gov

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