Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
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|ClinicalTrials.gov Identifier: NCT00004930|
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer Metastatic Cancer||Drug: doxorubicin hydrochloride||Phase 1|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|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|
|Actual Primary Completion Date :||February 2004|
|Actual Study Completion Date :||February 2004|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|