Clinical Trials Directory

Trials / Completed

CompletedNCT00020124

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

Status
Completed
Phase
Phase 1
Study type
Interventional
Enrollment
—
Sponsor
National Institutes of Health Clinical Center (CC) · NIH
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

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.

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.

Conditions

Interventions

TypeNameDescription
DRUGdoxorubicin hydrochloride

Timeline

Start date
2000-06-01
Completion
2002-12-01
First posted
2003-01-27
Last updated
2012-03-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00020124. Inclusion in this directory is not an endorsement.