Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
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|ClinicalTrials.gov Identifier: NCT00020124|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : March 15, 2012
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 or disease||Intervention/treatment||Phase|
|Lung Cancer Malignant Mesothelioma Metastatic Cancer||Drug: doxorubicin hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs|
|Study Start Date :||June 2000|
|Study Completion Date :||December 2002|
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 ClinicalTrials.gov identifier (NCT number): NCT00020124
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||David S. Schrump, MD||NCI - Surgery Branch|