Lung Cancer Clinical Trial
Official title:
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.
;
Primary Purpose: Treatment
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