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

Brief 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.

Tracking Information
First Received DateJuly 11, 2001
Last Changed DateMarch 14, 2012
Start DateJune 2000
Descriptive Information
PhasePhase 1
Study TypeInterventional
  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • Drug: doxorubicin hydrochloride
Detailed Description


- 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.

Recruitment Information
Recruitment StatusCompleted
Ages18 Years - N/A
Accepts Healthy VolunteersNo
Eligibility Criteria


- 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



- 18 and over

Performance status:

- ECOG 0-1

Life expectancy:

- More than 3 months


- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

- Hemoglobin at least 10 g/dL


- Bilirubin no greater than 1.0 mg/dL

- AST and ALT less than 1.5 times upper limit of normal


- Creatinine no greater than 1.6 mg/dL OR

- Creatinine clearance at least 60 mL/min


- LVEF at least 40% by MUGA scan or echocardiogram

- No unstable angina, congestive heart failure, or symptomatic arrhythmias


- 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


- 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


Biologic therapy:

- At least 4 weeks since prior biologic therapy and recovered

- No prior trastuzumab (Herceptin)


- 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


- 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


- See Disease Characteristics

- No prior total pneumonectomy


- No other concurrent experimental drug

Administrative Information
SponsorNational Institutes of Health Clinical Center (CC)
Verification DateMarch 2012
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