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

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Memorial Sloan Kettering Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin

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