Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00281944
Status:
COMPLETED
Last Update Posted:
2013-05-03
First Post:
2006-01-24
Brief Title:
Combination Chemotherapy in Treating Young Patients With Advanced Solid Tumors
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Multi-Center Phase Ib Study of Oxaliplatin NSC 266046 in Combination With Fluorouracil and Leucovorin in Pediatric Patients With Advanced Solid Tumors
Status:
COMPLETED
Status Verified Date:
2013-05
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 I trial is studying the side effects and best dose of oxaliplatin when given together with leucovorin and fluorouracil in treating young patients with advanced solid tumors Drugs used in chemotherapy such as oxaliplatin leucovorin and fluorouracil work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Determine the dose-limiting toxicities DLT and maximum tolerated dose MTD of oxaliplatin when given together with fluorouracil and leucovorin calcium in pediatric patients with recurrent or refractory solid tumors including tumors of the CNS
SECONDARY OBJECTIVES
I Determine the pharmacokinetic properties of oxaliplatin in this pediatric patient population
II Correlate alterations in accumulation of fludeoxyglucose F 18 with tumor response in those patients who can readily undergo a positron emission tomography PET or PETCT scan
III Assess the safety profile of this regimen in these patients IV Evaluate any preliminary evidence of anti-tumor activity of this regimen in these patients
OUTLINE This is an open-label multicenter dose-escalation study of oxaliplatin Patients are stratified according to solid tumor type non-CNS vs CNS
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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
After completion of study treatment patients are followed periodically
I Determine the dose-limiting toxicities DLT and maximum tolerated dose MTD of oxaliplatin when given together with fluorouracil and leucovorin calcium in pediatric patients with recurrent or refractory solid tumors including tumors of the CNS
SECONDARY OBJECTIVES
I Determine the pharmacokinetic properties of oxaliplatin in this pediatric patient population
II Correlate alterations in accumulation of fludeoxyglucose F 18 with tumor response in those patients who can readily undergo a positron emission tomography PET or PETCT scan
III Assess the safety profile of this regimen in these patients IV Evaluate any preliminary evidence of anti-tumor activity of this regimen in these patients
OUTLINE This is an open-label multicenter dose-escalation study of oxaliplatin Patients are stratified according to solid tumor type non-CNS vs CNS
Patients receive oxaliplatin IV over 2 hours and leucovorin calcium IV over 2 hours on day 1 followed by fluorouracil IV continuously over 46 hours on days 1-2 Courses repeat every 14 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of oxaliplatin 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
After completion of study treatment patients are followed periodically
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 |
|---|---|---|---|
| POETIC-COMIRB-040336 | None | None | None |
| 04-0336 | None | None | None |
| MSKCC-040336 | None | None | None |
| CDR0000454709 | None | None | None |
| NCI-6952 | None | None | None |