Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049543
Status:
COMPLETED
Last Update Posted:
2015-01-01
First Post:
2002-11-12
Brief Title:
Gefitinib in Treating Patients With Stage IB II or IIIA Non-small Cell Lung Cancer That Was Completely Removed by Surgery
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Prospective Randomized Double-Blind Placebo-Controlled Trial of the Epidermal Growth Factor Receptor Antagonist ZD1839 IRESSA in Completely Resected Primary Stage IB II and IIIA Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2014-03
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 randomized phase III trial studies how well gefitinib works in treating patients with stage IB II or IIIA non-small cell lung cancer that was completely removed by surgery Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth It is not yet known if gefitinib may be an effective treatment in preventing tumors from returning after they have been removed by surgery
Detailed Description:
PRIMARY OBJECTIVES
I To assess in comparison with placebo the impact of adjuvant therapy with two years of daily oral ZD1839 IRESSA gefitinib on the overall survival of patients with completely resected T1N1-2 T2N0-2 T3N0-2 non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To compare the disease-free survival in the placebo arm to the ZD1839 IRESSA arm
II To confirm the prognostic significance of epidermal growth factor receptor EGFR expression phosphorylation and mutations when present in the primary tumor
III To assess the ability of EGFR expression phosphorylation and mutations in the primary tumor to predict the relative impact of ZD1839 IRESSA on survival
IV To establish a comprehensive tumour bank linked to a clinical database for the further study of molecular markers in resected NSCLC
V To further evaluate toxicity related to ZD1839 IRESSA
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive gefitinib orally PO once daily QD for 2 years in the absence of disease progression or unacceptable toxicity
ARM II Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 6 months every 6 months for 3 years and then annually thereafter
I To assess in comparison with placebo the impact of adjuvant therapy with two years of daily oral ZD1839 IRESSA gefitinib on the overall survival of patients with completely resected T1N1-2 T2N0-2 T3N0-2 non-small cell lung cancer NSCLC
SECONDARY OBJECTIVES
I To compare the disease-free survival in the placebo arm to the ZD1839 IRESSA arm
II To confirm the prognostic significance of epidermal growth factor receptor EGFR expression phosphorylation and mutations when present in the primary tumor
III To assess the ability of EGFR expression phosphorylation and mutations in the primary tumor to predict the relative impact of ZD1839 IRESSA on survival
IV To establish a comprehensive tumour bank linked to a clinical database for the further study of molecular markers in resected NSCLC
V To further evaluate toxicity related to ZD1839 IRESSA
OUTLINE Patients are randomized to 1 of 2 treatment arms
ARM I Patients receive gefitinib orally PO once daily QD for 2 years in the absence of disease progression or unacceptable toxicity
ARM II Patients receive placebo PO QD for 2 years in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed up every 3 months for 6 months every 6 months for 3 years and then 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 |
|---|---|---|---|
| BR19 | OTHER | CTEP | None |
| NCI-2014-00650 | REGISTRY | None | None |
| SWOG-CAN-NCIC-BR19 | None | None | None |
| ECOG-CAN-NCIC-BR19 | None | None | None |
| BR19 | None | None | None |
| CDR0000258118 | None | None | None |
| CAN-NCIC-BR19 | None | None | None |
| BR19 | OTHER | None | None |