Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045318
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2002-09-06
Brief Title:
Exatecan Mesylate in Treating Patients With Advanced Solid Tumors and Kidney Dysfunction
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of DX-8951f Exatecan Mesylate for Injection in Patients With Renal Dysfunction
Status:
COMPLETED
Status Verified Date:
2003-04
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 exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction
PURPOSE Phase I trial to study the effectiveness of exatecan mesylate in treating patients who have advanced solid tumors and kidney dysfunction
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of exatecan mesylate in patients with advanced solid tumors and varying degrees of renal dysfunction
Determine the dose-limiting and non-dose-limiting toxic effects of this drug in these patients
Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients
Establish a model for dosing this drug in patients with impaired renal function
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to severity of renal dysfunction normal vs mild vs moderate vs severe
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each renal dysfunction stratum receive escalating doses of exatecan mesylate 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 in the normal renal function stratum do not undergo dose escalation
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 45 patients 6 normal 9 mild 12 moderate and 18 severe renal dysfunction will be accrued for this study within 15 years
Determine the maximum tolerated dose of exatecan mesylate in patients with advanced solid tumors and varying degrees of renal dysfunction
Determine the dose-limiting and non-dose-limiting toxic effects of this drug in these patients
Determine the effects of renal dysfunction on the plasma pharmacokinetics and pharmacodynamics of this drug in these patients
Establish a model for dosing this drug in patients with impaired renal function
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to severity of renal dysfunction normal vs mild vs moderate vs severe
Patients receive exatecan mesylate IV over 30 minutes on days 1-5 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients in each renal dysfunction stratum receive escalating doses of exatecan mesylate 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 in the normal renal function stratum do not undergo dose escalation
Patients are followed every 3 months
PROJECTED ACCRUAL A total of 45 patients 6 normal 9 mild 12 moderate and 18 severe renal dysfunction will be accrued for this study within 15 years
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-G02-2103 | Registry Identifier | PDQ Physician Data Query | None |
| UCLA-0201008 | None | None | None |
| CDR0000256866 | REGISTRY | None | None |