Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00014170
Status:
COMPLETED
Last Update Posted:
2013-07-16
First Post:
2001-04-10
Brief Title:
Gefitinib in Treating Patients With Newly Diagnosed Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Study Of ZD1839 NSC 715055 In Newly Diagnosed Patients With Glioblastoma Grade 4 Astrocytoma
Status:
COMPLETED
Status Verified Date:
2013-06
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:
Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of glioblastoma multiforme Phase II trial to study the effectiveness of gefitinib in treating patients who have newly diagnosed glioblastoma multiforme
Detailed Description:
OBJECTIVES
I Determine treatment effectiveness of gefitinib in terms of response rate time to progression survival at 52 weeks progression-free survival at 6 months and overall survival in patients with newly diagnosed glioblastoma multiforme
II Determine the toxic effects of this drug in these patients III Assess fatigue depression excessive daytime somnolence and quality of life in patients treated with this drug
IV Assess individual variation in responses pharmacokinetic parameters andor biological correlates due to genetic differences in enzymes involved in transport metabolism andor mechanism of action of this drug in these patients
V Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib daily Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each treatment course every 4 months for 1 year every 6 months for 4 years and then annually for 5 years
Patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 92 patients will be accrued for this study within 14 months
I Determine treatment effectiveness of gefitinib in terms of response rate time to progression survival at 52 weeks progression-free survival at 6 months and overall survival in patients with newly diagnosed glioblastoma multiforme
II Determine the toxic effects of this drug in these patients III Assess fatigue depression excessive daytime somnolence and quality of life in patients treated with this drug
IV Assess individual variation in responses pharmacokinetic parameters andor biological correlates due to genetic differences in enzymes involved in transport metabolism andor mechanism of action of this drug in these patients
V Determine if the type of epidermal growth factor receptor affects tumor response and outcome in patients treated with this drug
OUTLINE This is a multicenter study
Patients receive oral gefitinib daily Courses repeat every 8 weeks for up to 2 years in the absence of disease progression or unacceptable toxicity
Quality of life is assessed at baseline before each treatment course every 4 months for 1 year every 6 months for 4 years and then annually for 5 years
Patients are followed every 8 weeks until tumor progression and then every 3 months for 5 years and annually for up to 10 years Patients removed from study treatment for reasons other than disease progression are followed every 4 months for 1 year every 6 months for 4 years and then annually for 5 years
PROJECTED ACCRUAL A total of 92 patients will be accrued for this study within 14 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 |
|---|---|---|---|
| U10CA025224 | NIH | None | httpsreporternihgovquickSearchU10CA025224 |
| N0074 | None | None | None |
| CDR0000068511 | None | None | None |
| NCCTG-N0074 | None | None | None |