Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
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.
|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:||July 1999|
|Study Completion Date:||February 2004|
|Primary Completion Date:||February 2004 (Final data collection date for primary outcome measure)|
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004930
|United States, New York|
|Memorial Sloan-Kettering Cancer Center|
|New York, New York, United States, 10021|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210|
|Study Chair:||Naiyer Rizvi, MD||Memorial Sloan Kettering Cancer Center|