Ignite Creation Date:
2024-05-05 @ 11:28 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00052208
Status:
COMPLETED
Last Update Posted:
2020-10-30
First Post:
2003-01-24
Brief Title:
Gefitinib and Radiation Therapy in Treating Patients With Glioblastoma Multiforme
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Study of an Oral Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor EGFR-TKI ZD 1839 Iressa NSC 715055 With Radiation Therapy in Glioblastoma Multiforme
Status:
COMPLETED
Status Verified Date:
2020-10
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:
This phase III trial studies the side effects and best dose of gefitinib when given together with radiation therapy and to see how well it works in treating patients with glioblastoma multiforme Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Radiation therapy uses high energy x rays to kill tumor cells Giving gefitinib together with radiation therapy may be an effective treatment for glioblastoma multiforme
Detailed Description:
PRIMARY OBJECTIVES
I To identify the maximum tolerated dose of ZD 1839 gefitinib when given concurrently with cranial radiotherapy
II To determine if ZD 1839 given orally on a daily basis starting at the time of conventional radiation therapy RT may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme compared with historical controls stratifying by epidermal growth factor receptor EGFR status
III To determine in a multi-institutional setting the feasibility and toxicity of prescribing ZD 1839
SECONDARY OBJECTIVES
I Whether ZD 1839 also improves progression-free survival in these patients
OUTLINE This is a phase I dose-escalation study of gefitinib followed by a phase II study
Patients receive gefitinib orally PO once daily QD for 7 weeks Beginning 1 week after initiation of gefitinib patients undergo radiation therapy QD 5 days a week for 6 weeks Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 4 months for 1 year every 6 months for 2 years and annually thereafter
I To identify the maximum tolerated dose of ZD 1839 gefitinib when given concurrently with cranial radiotherapy
II To determine if ZD 1839 given orally on a daily basis starting at the time of conventional radiation therapy RT may improve the overall survival of adults with newly-diagnosed supratentorial glioblastoma multiforme compared with historical controls stratifying by epidermal growth factor receptor EGFR status
III To determine in a multi-institutional setting the feasibility and toxicity of prescribing ZD 1839
SECONDARY OBJECTIVES
I Whether ZD 1839 also improves progression-free survival in these patients
OUTLINE This is a phase I dose-escalation study of gefitinib followed by a phase II study
Patients receive gefitinib orally PO once daily QD for 7 weeks Beginning 1 week after initiation of gefitinib patients undergo radiation therapy QD 5 days a week for 6 weeks Treatment with gefitinib continues for up to 18 months in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 4 months for 1 year every 6 months for 2 years and annually thereafter
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 |
|---|---|---|---|
| U10CA021661 | NIH | None | httpsreporternihgovquickSearchU10CA021661 |
| RTOG-0211 | None | None | None |
| CDR0000069330 | None | None | None |
| RTOG-BR-0211 | None | None | None |