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

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00020124
First received: July 11, 2001
Last updated: March 14, 2012
Last verified: March 2012

July 11, 2001
March 14, 2012
June 2000
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Complete list of historical versions of study NCT00020124 on ClinicalTrials.gov Archive Site
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Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
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. 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.

OBJECTIVES:

  • 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.

Interventional
Phase 1
Primary Purpose: Treatment
  • Lung Cancer
  • Malignant Mesothelioma
  • 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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December 2002
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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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00020124
000088, 00-C-0088, CDR0000067718
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National Institutes of Health Clinical Center (CC)
National Cancer Institute (NCI)
Study Chair: David S. Schrump, MD NCI - Surgery Branch
National Institutes of Health Clinical Center (CC)
March 2012

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