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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004930
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief 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.

Condition or disease Intervention/treatment Phase
Lung Cancer Metastatic Cancer Drug: doxorubicin hydrochloride Phase 1

Detailed Description:


  • 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  (Clinical Trial)
Primary Purpose: Treatment
Official Title: Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
Study Start Date : July 1999
Actual Primary Completion Date : February 2004
Actual Study Completion Date : February 2004

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 160,000/mm^3
  • Hemoglobin at least 9 g/dL


  • Bilirubin no greater than 1.0 mg/dL
  • AST/ALT less than 1.5 times upper limit of normal


  • Creatinine no greater than 1.2 mg/dL OR
  • Creatinine clearance at least 50 mL/min


  • LVEF normal by MUGA scan or echocardiography
  • No unstable angina
  • No congestive heart failure
  • No symptomatic arrhythmias


  • 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


  • 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


Biologic therapy:

  • Not specified


  • 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


  • 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


  • See Disease Characteristics
  • No prior pneumonectomy


  • No daily or as necessary respiratory drugs via inhaler or nebulizer
  • No other concurrent experimental drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004930

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
United States, Ohio
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center Identifier: NCT00004930     History of Changes
Other Study ID Numbers: 99-049
CDR0000067614 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
lung metastases
bronchoalveolar cell lung cancer

Additional relevant MeSH terms:
Lung Neoplasms
Neoplasm Metastasis
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Liposomal doxorubicin
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action