Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00045110
Status:
COMPLETED
Last Update Posted:
2017-08-17
First Post:
2002-09-06
Brief Title:
Erlotinib in Treating Patients With Recurrent Malignant Glioma or Recurrent or Progressive Meningioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial of OSI-774 in Patients With Recurrent Malignant Gliomas and Malignant Gliomas Post Radiation Therapy
Status:
COMPLETED
Status Verified Date:
2017-07
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:
Phase III trial to study the effectiveness of erlotinib in treating patients who have recurrent malignant glioma or recurrent or progressive meningioma Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth
Detailed Description:
OBJECTIVES
Phase 1 I Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma
II Determine the safety profile of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
Phase 2 I Determine the 6-month progression-free survival recurrent malignant glioma II12-month survival of patients treated with this drug stable glioblastoma post radiation therapy
Phase 2 - Secondary Recurrent Malignant Glioma I Objective Tumor Response rate associated with erlotinib therapy in recurrent or progressive malignant glioma
III 12-month survival of patients treated with this drug Determine the safety profile of this drug in these patients IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to study phase I vs II concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no histology recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM preoperative candidacy yes vs no and concurrent steroids yes vs no
Phase I Patients concurrently receiving EIAEDs receive oral erlotinib once daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose
Patients are followed for survival
Phase 1 I Determine the maximum tolerated dose of erlotinib in patients with recurrent malignant glioma or recurrent or progressive meningioma
II Determine the safety profile of this drug in these patients III Determine the pharmacokinetics of this drug in these patients
Phase 2 I Determine the 6-month progression-free survival recurrent malignant glioma II12-month survival of patients treated with this drug stable glioblastoma post radiation therapy
Phase 2 - Secondary Recurrent Malignant Glioma I Objective Tumor Response rate associated with erlotinib therapy in recurrent or progressive malignant glioma
III 12-month survival of patients treated with this drug Determine the safety profile of this drug in these patients IV Determine the pharmacokinetics of this drug in these patients
OUTLINE This is a dose-escalation multicenter study Patients are stratified according to study phase I vs II concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no histology recurrent GBM vs recurrent anaplastic glioma vs recurrent meningioma vs stable GBM preoperative candidacy yes vs no and concurrent steroids yes vs no
Phase I Patients concurrently receiving EIAEDs receive oral erlotinib once daily Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib until the maximum tolerated dose MTD is determined The MTD is the dose preceding that at which at least 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
Phase II Once the MTD is determined additional patients concurrently receiving EIAEDs are treated with erlotinib as above at the phase II dose Patients not concurrently receiving EIAEDs are treated with erlotinib as above at a predetermined dose
Patients are followed for survival
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 |
|---|---|---|---|
| U01CA062399 | NIH | CTEP | httpsreporternihgovquickSearchU01CA062399 |
| NCI-2012-02490 | REGISTRY | None | None |
| NCI-03-C-0114 | None | None | None |
| CDR0000256358 | None | None | None |
| NABTC-01-03 | OTHER | None | None |
| NABTC-01-03 | OTHER | None | None |