Ignite Creation Date:
2024-05-05 @ 11:24 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00025207
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2001-10-11
Brief Title:
Gefitinib in Treating Patients With Malignant Mesothelioma
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study Of ZD 1839 NSC 715055 IND 61187 In Patients With Malignant Mesothelioma
Status:
COMPLETED
Status Verified Date:
2013-01
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 II trial to study the effectiveness of gefitinib in treating patients who have malignant mesothelioma Biological therapies such as gefitinib may interfere with the growth of the tumor cells and slow the growth of malignant mesothelioma
Detailed Description:
OBJECTIVES
I Determine the activity of gefitinib in terms of failure-free survival in patients with malignant mesothelioma
II Determine the response rate in patients treated with this drug III Determine the toxicity of this drug in these patients IV Determine the overall survival of patients treated with this drug V Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-21 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 7-10 months
I Determine the activity of gefitinib in terms of failure-free survival in patients with malignant mesothelioma
II Determine the response rate in patients treated with this drug III Determine the toxicity of this drug in these patients IV Determine the overall survival of patients treated with this drug V Determine whether overexpression of epidermal growth factor receptor and expression of cyclo-oxygenase-2 can predict the effectiveness of this drug in these patients
OUTLINE This is a multicenter study
Patients receive oral gefitinib once daily on days 1-21 Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 2 months for 1 year and then every 6 months for up to 3 years
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study within 7-10 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 |
|---|---|---|---|
| CDR0000068938 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |
| CLB-30101 | None | None | None |
| U10CA031946 | NIH | None | None |