Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004930
Status:
COMPLETED
Last Update Posted:
2013-06-19
First Post:
2000-03-07
Brief Title:
Inhaled Doxorubicin in Treating Patients With Primary Lung Cancer or Lung Metastases
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
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:
2013-06
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
PURPOSE Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases
PURPOSE Phase I trial to study the effectiveness of inhaled doxorubicin in treating patients who have primary lung cancer or lung metastases
Detailed Description:
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
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 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 |
|---|---|---|---|
| NCI-G00-1696 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067614 | REGISTRY | None | None |
| BMI-98-DOX-001 | None | None | None |