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Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
This study has been completed.
First Received: July 11, 2001   Last Updated: December 13, 2008   History of Changes
Sponsored by: National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00020124
  Purpose

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.


Condition Intervention Phase
Lung Cancer
Malignant Mesothelioma
Metastatic Cancer
Thymoma and Thymic Carcinoma
Drug: doxorubicin hydrochloride
Phase I

Study Type: Interventional
Study Design: Treatment
Official Title: Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 2000
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00020124

Locations
United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Sponsors and Collaborators
Investigators
Study Chair: David S. Schrump, MD NCI - Surgery Branch
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067718, NCI-00-C-0088
Study First Received: July 11, 2001
Last Updated: December 13, 2008
ClinicalTrials.gov Identifier: NCT00020124     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
recurrent non-small cell lung cancer
extensive stage small cell lung cancer
recurrent small cell lung cancer
advanced malignant mesothelioma
recurrent malignant mesothelioma
invasive thymoma and thymic carcinoma
recurrent thymoma and thymic carcinoma
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
pulmonary carcinoid tumor
lung metastases

Study placed in the following topic categories:
Thoracic Neoplasms
Doxorubicin
Recurrence
Carcinoma
Carcinoma, Small Cell
Anti-Bacterial Agents
Respiratory Tract Diseases
Lung Neoplasms
Lung Diseases
Thymoma
Thymus Neoplasms
Neoplasm Metastasis
Non-small Cell Lung Cancer
Mesothelioma
Carcinoid Tumor
Adenoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Thoracic Neoplasms
Respiratory Tract Neoplasms
Neoplasms by Histologic Type
Antineoplastic Agents
Neoplasms, Mesothelial
Antibiotics, Antineoplastic
Pharmacologic Actions
Doxorubicin
Carcinoma
Neoplastic Processes
Neoplasms
Pathologic Processes
Neoplasms by Site
Respiratory Tract Diseases
Lung Neoplasms
Therapeutic Uses
Lung Diseases
Thymoma
Thymus Neoplasms
Neoplasm Metastasis
Mesothelioma
Adenoma
Neoplasms, Complex and Mixed
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on September 11, 2009