Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00227032
Status:
TERMINATED
Last Update Posted:
2012-03-06
First Post:
2005-09-23
Brief Title:
Erlotinib in Treating Patients With Progressive Glioblastoma Multiforme
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase I Study of Erlotinib Administered Every 72 Hours in Patients With Glioblastoma Multiforme With PharmacokineticPharmacodynamic Correlates
Status:
TERMINATED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Loss of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase I trial is studying the side effects and best dose of erlotinib in treating patients with progressive glioblastoma multiforme
PURPOSE This phase I trial is studying the side effects and best dose of erlotinib in treating patients with progressive glioblastoma multiforme
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of erlotinib hydrochloride when administered in escalating doses every 72 hours in patients with progressive glioblastoma multiforme
Secondary
Determine the relationship between plasma and cerebrospinal fluid CSF concentrations of erlotinib hydrochloride in these patients
Determine the relationship between plasma and CSF concentrations of erlotinib hydrochloride in patients not receiving concurrent enzyme-inducing antiepileptic drugs EIAEDs vs those receiving concurrent EIAEDs
Correlate CYP3A4 activity as measured by midazolam hydrochloride clearance with plasma clearance of erlotinib hydrochloride in these patients
Correlate CYP1A2 activity as measured by the 4-hour paraxanthine 17Xcaffeine 137X plasma ratio with plasma clearance of erlotinib hydrochloride in these patients
Determine preliminarily objective response and disease progression in patients treated with erlotinib hydrochloride
Correlate the presence of EGFRvIII mutation with objective response and disease progression in patients treated with erlotinib hydrochloride
OUTLINE This is an open-label dose-escalation study Patients are stratified according to use of concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no
Patients receive oral erlotinib hydrochloride once every 72 hours for 28 days Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose MTD is determined or preliminary results show no direct relationship between plasma and cerebrospinal fluid concentrations The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
NOTE Interim enrollment of patients is allowed these patients receive the current approved dose of erlotinib hydrochloride
Patients undergo blood sample collection periodically on day 13 for pharmacokinetic studies The pharmacokinetic study comprises midazolam hydrochloride and caffeine clearance assessment and correlation of these assessments with CYP3A4 activity and CYP1A2 activity
Paraffin-embedded and frozen tumor tissue is obtained from patients who underwent prior surgical resection for analysis of wild-type EGFR and EGFRvIII mutation by immunohistochemistry
Quality of life is assessed at baseline and then at 1 month and 6 months
After completion of study therapy patients are followed periodically
Primary
Determine the maximum tolerated dose of erlotinib hydrochloride when administered in escalating doses every 72 hours in patients with progressive glioblastoma multiforme
Secondary
Determine the relationship between plasma and cerebrospinal fluid CSF concentrations of erlotinib hydrochloride in these patients
Determine the relationship between plasma and CSF concentrations of erlotinib hydrochloride in patients not receiving concurrent enzyme-inducing antiepileptic drugs EIAEDs vs those receiving concurrent EIAEDs
Correlate CYP3A4 activity as measured by midazolam hydrochloride clearance with plasma clearance of erlotinib hydrochloride in these patients
Correlate CYP1A2 activity as measured by the 4-hour paraxanthine 17Xcaffeine 137X plasma ratio with plasma clearance of erlotinib hydrochloride in these patients
Determine preliminarily objective response and disease progression in patients treated with erlotinib hydrochloride
Correlate the presence of EGFRvIII mutation with objective response and disease progression in patients treated with erlotinib hydrochloride
OUTLINE This is an open-label dose-escalation study Patients are stratified according to use of concurrent enzyme-inducing antiepileptic drugs EIAEDs yes vs no
Patients receive oral erlotinib hydrochloride once every 72 hours for 28 days Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of erlotinib hydrochloride until the maximum tolerated dose MTD is determined or preliminary results show no direct relationship between plasma and cerebrospinal fluid concentrations The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity
NOTE Interim enrollment of patients is allowed these patients receive the current approved dose of erlotinib hydrochloride
Patients undergo blood sample collection periodically on day 13 for pharmacokinetic studies The pharmacokinetic study comprises midazolam hydrochloride and caffeine clearance assessment and correlation of these assessments with CYP3A4 activity and CYP1A2 activity
Paraffin-embedded and frozen tumor tissue is obtained from patients who underwent prior surgical resection for analysis of wild-type EGFR and EGFRvIII mutation by immunohistochemistry
Quality of life is assessed at baseline and then at 1 month and 6 months
After completion of study therapy 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 |
|---|---|---|---|
| CDR0000550155 | OTHER | PDQ number | None |