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

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ClinicalTrials.gov Identifier: NCT00004930
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

March 7, 2000
January 27, 2003
June 19, 2013
July 1999
February 2004   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004930 on ClinicalTrials.gov Archive Site
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Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Lung Cancer
  • Metastatic Cancer
Drug: doxorubicin hydrochloride
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2004
February 2004   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00004930
99-049
CDR0000067614 ( Registry Identifier: PDQ (Physician Data Query) )
BMI-98-DOX-001
NCI-G00-1696
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Naiyer Rizvi, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP