Inhaled Doxorubicin in Treating Patients 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.
Drug: doxorubicin hydrochloride
|Study Design:||Primary Purpose: Treatment|
|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|
- 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.
|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|