Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00411047
Status:
COMPLETED
Last Update Posted:
2013-05-14
First Post:
2006-12-11
Brief Title:
Gefitinib in Treating Patients With Previously Untreated Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
A Phase II Open Label Study of Gefitinib IRESSA in Treatment-Naïve Subjects With Stage IIIB or IV Non-Small Cell Lung Cancer and Somatic Activating Mutations in the Epidermal Growth Factor Receptor
Status:
COMPLETED
Status Verified Date:
2013-05
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 Gefitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well gefitinib works in treating patients with previously untreated stage IIIB or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the objective tumor response rate in patients with previously untreated stage IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK region of the epidermal growth factor receptor EGFR gene treated with gefitinib
Secondary
Determine response duration progression-free survival and overall survival of patients treated with this drug
Determine the safety of this drug in these patients
Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict response in patients treated with this drug
Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict toxicity of this drug in these patients
Define a molecular profile in patients who initially respond to treatment with this drug but subsequently progress on therapy
Determine the significance of germline polymorphisms of the EGFR gene somatic amplification of the EGFR gene and other molecular factors for their association with clinical outcome parameters in these patients
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 2 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
Primary
Determine the objective tumor response rate in patients with previously untreated stage IIIB or IV non-small cell lung cancer with somatic activating mutations in the TK region of the epidermal growth factor receptor EGFR gene treated with gefitinib
Secondary
Determine response duration progression-free survival and overall survival of patients treated with this drug
Determine the safety of this drug in these patients
Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict response in patients treated with this drug
Compare the ability of various somatic activating mutations in the TK region of the EGFR gene to predict toxicity of this drug in these patients
Define a molecular profile in patients who initially respond to treatment with this drug but subsequently progress on therapy
Determine the significance of germline polymorphisms of the EGFR gene somatic amplification of the EGFR gene and other molecular factors for their association with clinical outcome parameters in these patients
OUTLINE This is an open-label study
Patients receive oral gefitinib once daily on days 1-28 Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 2 months
PROJECTED ACCRUAL A total of 30 patients will be accrued for this study
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 |
|---|---|---|---|
| IRUSIRES0483 | OTHER | AstraZeneca | None |