Ignite Creation Date:
2024-05-05 @ 11:42 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00112892
Status:
COMPLETED
Last Update Posted:
2014-01-13
First Post:
2005-06-02
Brief Title:
Irinotecan and Selenium in Treating Patients With Advanced Solid Tumors
Sponsor:
Roswell Park Cancer Institute
Organization:
Roswell Park Cancer Institute
Study Overview
Official Title:
A Phase I and Pharmacokinetic Study of Selenomethionine With Fixed Dose Irinotecan in Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2014-01
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 such as irinotecan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Selenium may allow higher doses of irinotecan to be given Giving irinotecan together with selenium may kill more tumor cells
PURPOSE This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors
PURPOSE This phase I trial is studying the side effects and best dose of selenium when given together with irinotecan in treating patients with advanced solid tumors
Detailed Description:
OBJECTIVES
Primary
Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors
Secondary
Determine the pharmacokinetics of this regimen in these patients
Determine the toxic effects of this regimen in these patients
Determine any observed tumor response to this regimen in these patients
OUTLINE This is a dose-escalation study of selenium
Patients receive a loading dose of oral selenium twice daily on days -6 to 0 Patients then receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
NOTE The loading dose is administered prior to course 1 only
Cohorts of 3-6 patients receive escalating doses of selenium 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 2-36 patients will be accrued for this study within 18 months
Primary
Determine the optimal loading and maintenance doses of selenium necessary to achieve selenium concentrations exceeding 15 μM when administered with irinotecan in patients with advanced solid tumors
Secondary
Determine the pharmacokinetics of this regimen in these patients
Determine the toxic effects of this regimen in these patients
Determine any observed tumor response to this regimen in these patients
OUTLINE This is a dose-escalation study of selenium
Patients receive a loading dose of oral selenium twice daily on days -6 to 0 Patients then receive oral selenium once daily on days 1-42 and irinotecan IV over 90 minutes on days 1 8 15 and 22 Courses repeat every 42 days in the absence of disease progression or unacceptable toxicity
NOTE The loading dose is administered prior to course 1 only
Cohorts of 3-6 patients receive escalating doses of selenium 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 At least 6 patients are treated at the MTD
PROJECTED ACCRUAL A total of 2-36 patients will be accrued for this study within 18 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| RPCI-I-32804 | None | None | None |