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

• Status: Completed
• Trial end date: 2002-12-01
• 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. 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.

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

Details

• Lead Sponsor: National Institutes of Health Clinical Center (CC)
• Collaborator: National Cancer Institute (NCI)
• Treatments: Doxorubicin; Liposomal doxorubicin

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