Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00020124
Status:
COMPLETED
Last Update Posted:
2012-03-15
First Post:
2001-07-11
Brief Title:
Inhaled Doxorubicin in Treating Patients With Advanced Solid Tumors Affecting the Lungs
Sponsor:
National Institutes of Health Clinical Center CC
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Phase I and Clinical Pharmacologic Study of Inhaled Doxorubicin in Adults With Advanced Solid Tumors Affecting the Lungs
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Giving drugs in different ways may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs
PURPOSE Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have advanced solid tumors affecting the lungs
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients
Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity
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 3 weeks and 3 months
PROJECTED ACCRUAL Approximately 33 patients will be accrued for this study within 18-24 months
Determine the maximum tolerated dose and phase II dose of inhaled doxorubicin in patients with advanced solid tumors affecting the lungs
Determine the toxicity of this regimen in these patients
Determine the pharmacokinetic profile of inhaled doxorubicin in blood in these patients
Determine the relationship between pharmacodynamic parameters and toxic effects of this regimen in these patients
OUTLINE This is a dose-escalation study
Patients receive inhaled doxorubicin every 3 weeks for up to 3 doses Patients with stable or responding disease may receive additional doses in the absence of disease progression or unacceptable toxicity
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 3 weeks and 3 months
PROJECTED ACCRUAL Approximately 33 patients will be accrued for this study within 18-24 months
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CDR0000067718 | None | None | None |
| 00-C-0088 | None | None | None |