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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. PURPOSE: Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases.
OBJECTIVES: * Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin administered every 3 weeks in patients with primary lung cancer or cancer metastatic to the lung. * Determine the toxic effects and pharmacokinetic profile of this regimen in this patient population. * Examine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients. * Obtain preliminary evidence of therapeutic activity of this regimen in these patients. OUTLINE: This is a dose-escalation study. Patients receive inhaled doxorubicin every 3 weeks. Treatment continues for a maximum of 3 courses in the absence of unacceptable toxicity or disease progression. Patients may reenter at a higher dose level after a 3-month waiting period. 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 6 weeks. PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Memorial Sloan-Kettering Cancer Center
New York, New York, United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, United States
Start Date
July 1, 1999
Primary Completion Date
February 1, 2004
Completion Date
February 1, 2004
Last Updated
June 19, 2013
doxorubicin hydrochloride
DRUG
Lead Sponsor
Memorial Sloan Kettering Cancer Center
Collaborators
NCT06498635
NCT06305754
Data Source & Attribution
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