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

Phase 1
18 Years
Not Enrolling
Lung Cancer, Malignant Mesothelioma, Metastatic Cancer

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Trial Information

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


- 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

- 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

Inclusion 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

Type of Study:


Study Design:

Primary Purpose: Treatment

Principal Investigator

David S. Schrump, MD

Investigator Role:

Study Chair

Investigator Affiliation:

NCI - Surgery Branch


United States: Federal Government

Study ID:




Start Date:

June 2000

Completion Date:

December 2002

Related Keywords:

  • Lung Cancer
  • Malignant Mesothelioma
  • Metastatic Cancer
  • 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
  • Lung Neoplasms
  • Mesothelioma
  • Neoplasm Metastasis
  • Neoplasms
  • Neoplasms, Second Primary



Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support Bethesda, Maryland  20892-1182