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.
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.
;
Primary Purpose: Treatment
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