Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00027625
Status:
COMPLETED
Last Update Posted:
2018-06-27
First Post:
2001-12-07
Brief Title:
Gefitinib Plus Temozolomide in Treating Patients With Malignant Primary Glioma
Sponsor:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Organization:
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Study Overview
Official Title:
A Phase I Study Of ZD 1839 And Temozolomide For The Treatment Of Gliomas
Status:
COMPLETED
Status Verified Date:
2018-06
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:
RATIONALE Biological therapies such as gefitinib may interfere with the growth of cancer cells and slow the growth of the tumor Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Combining gefitinib with chemotherapy may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma
PURPOSE Phase I trial to study the effectiveness of combining gefitinib with temozolomide in treating patients who have malignant primary glioma
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of gefitinib Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs yes vs no
Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only For the second and subsequent courses patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib 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
Patients are followed every 2 months for 1 year and then every 3-6 months thereafter
PROJECTED ACCRUAL Approximately 3-42 patients will be accrued for this study within 1-14 months
Determine the maximum tolerated dose of gefitinib when given in combination with temozolomide in patients with malignant primary glioma
Determine the toxic effects of this regimen in these patients
Determine the pharmacokinetics of this regimen in these patients
OUTLINE This is a multicenter dose-escalation study of gefitinib Patients are stratified according to use of concurrent enzyme-inducing anti-epileptic drugs yes vs no
Patients receive oral gefitinib once daily on days 1-35 and oral temozolomide once daily on days 8-12 for the first course only For the second and subsequent courses patients receive oral gefitinib once daily on days 1-28 and oral temozolomide once daily on days 1-5 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
Cohorts of 3-6 patients receive escalating doses of gefitinib 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
Patients are followed every 2 months for 1 year and then every 3-6 months thereafter
PROJECTED ACCRUAL Approximately 3-42 patients will be accrued for this study within 1-14 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| CDR0000069049 | REGISTRY | PDQ Physician Data Query | None |