Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005856
Status:
TERMINATED
Last Update Posted:
2013-01-24
First Post:
2000-06-02
Brief Title:
Oxaliplatin in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase III Trial of Oxaliplatin as Neoadjuvant Treatment in Adults With Newly Diagnosed Glioblastoma Multiforme
Status:
TERMINATED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Administratively complete
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase III trial is studying the side effects and best dose of oxaliplatin in treating patients with newly diagnosed glioblastoma multiforme Drugs used in chemotherapy such as oxaliplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
Detailed Description:
OBJECTIVES
I Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be metabolized by P450
II Determine the dose-limiting toxicity and safety profile of this drug in this patient population
III Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients
IV Determine the radiographic response rate in patients treated with this drug
V Determine survival and drug toxicity in these patients
OUTLINE This is a phase I dose-escalation study of oxaliplatin followed by a phase II study Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 yes vs modestno or no drugs
Phase I Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients per stratum 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 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin as in phase I at the MTD determined in phase I
Patients are followed at 1 month every 2 months until disease progression and then monthly thereafter
PROJECTED ACCRUAL Approximately 24 patients 12 per stratum will be accrued for the phase I part of this study within 8-12 months A total of 18-35 patients will be accrued for the phase II part of this study within 5-12 months
I Determine the maximum tolerated dose of oxaliplatin in patients with newly diagnosed glioblastoma multiforme who are receiving or not receiving anticonvulsants known to be metabolized by P450
II Determine the dose-limiting toxicity and safety profile of this drug in this patient population
III Assess the pharmacokinetics of this drug on this schedule and determine the effects of P450-inducing anticonvulsants on the pharmacokinetics in these patients
IV Determine the radiographic response rate in patients treated with this drug
V Determine survival and drug toxicity in these patients
OUTLINE This is a phase I dose-escalation study of oxaliplatin followed by a phase II study Patients are stratified according to whether concurrent anticonvulsant drugs induce P450 yes vs modestno or no drugs
Phase I Patients receive oxaliplatin IV over 2 hours on day 1 Treatment repeats every 14 days for a maximum of 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-6 patients per stratum 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 6 patients experience dose-limiting toxicity
Phase II Patients receive oxaliplatin as in phase I at the MTD determined in phase I
Patients are followed at 1 month every 2 months until disease progression and then monthly thereafter
PROJECTED ACCRUAL Approximately 24 patients 12 per stratum will be accrued for the phase I part of this study within 8-12 months A total of 18-35 patients will be accrued for the phase II part of this study within 5-12 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 |
|---|---|---|---|
| 9902 | None | None | None |
| U01CA062475 | NIH | None | None |
| CDR0000067883 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU01CA062475 |