Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
- 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
- Determine the toxic effects and pharmacokinetic profile of this regimen in this patient
- 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.
Primary Purpose: Treatment
Naiyer Rizvi, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|Arthur G. James Cancer Hospital - Ohio State University||Columbus, Ohio 43210|