Ignite Creation Date:
2024-05-05 @ 11:37 AM
Last Modification Date:
2024-10-26 @ 9:10 AM
Study NCT ID:
NCT00091182
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2004-09-07
Brief Title:
Oxaliplatin in Treating Young Patients With Recurrent Solid Tumors That Have Not Responded to Previous Treatment
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Oxaliplatin in Children With Recurrent Solid Tumors
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:
This phase II trial is studying how well oxaliplatin works in treating young patients with recurrent solid tumors that have not responded to previous treatment Drugs used in chemotherapy such as oxaliplatin work in different ways to stop tumor cells from dividing so they stop growing or die
Detailed Description:
OBJECTIVES
I Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin
II Determine the cumulative toxicity of this drug in these patients III Determine the pharmacokinetic profile of this drug in these patients IV Determine time to progression and overall survival of patients treated with this drug
V Correlate the extent of oxaliplatin exposure with response in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease type
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity
I Determine the response rate in children with recurrent or refractory solid tumors treated with oxaliplatin
II Determine the cumulative toxicity of this drug in these patients III Determine the pharmacokinetic profile of this drug in these patients IV Determine time to progression and overall survival of patients treated with this drug
V Correlate the extent of oxaliplatin exposure with response in these patients
OUTLINE This is a multicenter study Patients are stratified according to disease type
Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| U10CA098543 | NIH | None | httpsreporternihgovquickSearchU10CA098543 |
| ADVL0421 | None | None | None |
| COG-ADVL0421 | None | None | None |
| CDR0000384560 | None | None | None |