Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00024284
Status:
COMPLETED
Last Update Posted:
2013-04-05
First Post:
2001-09-13
Brief Title:
Carboplatin and Irinotecan in Treating Children With Refractory Solid Tumors
Sponsor:
Bristol-Myers Squibb
Organization:
Bristol-Myers Squibb
Study Overview
Official Title:
A Phase I Study Of Carboplatin And Irinotecan In Patients 1-21 Years Of Age With Refractory Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-04
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 combining carboplatin and irinotecan in treating children who have refractory solid tumors
PURPOSE Phase I trial to study the effectiveness of combining carboplatin and irinotecan in treating children who have refractory solid tumors
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors
Determine the safety profile and dose-limiting toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the preliminary anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of carboplatin and irinotecan
Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 25-30 patients will be accrued for this study within 6-9 months
Determine the maximum tolerated dose and recommended phase II dose of carboplatin and irinotecan in children with refractory solid tumors
Determine the safety profile and dose-limiting toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
Determine the preliminary anti-tumor activity of this regimen in these patients
OUTLINE This is a dose-escalation study of carboplatin and irinotecan
Patients receive carboplatin IV over 50 minutes on day 1 and irinotecan IV over 1 hour on days 1-5 and 8-12 Treatment repeats every 21 days for up to 12 courses in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of carboplatin and irinotecan until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Patients are followed for at least 30 days
PROJECTED ACCRUAL A total of 25-30 patients will be accrued for this study within 6-9 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 |
|---|---|---|---|
| NCI-G01-2016 | None | None | None |
| BMS-CA124-001 | None | None | None |
| CNMC-2782 | None | None | None |
| MSKCC-01071 | None | None | None |
| SJCRH-CARCPT | None | None | None |