Back to resultsFirst-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Primary Purpose
Pulmonary Cancer
Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Gefitinib
Sponsored by
About this trial
This is an interventional treatment trial for Pulmonary Cancer focused on measuring Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation, Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation, Recurrent pulmonary adenocarcinoma with EGFR mutation
Eligibility Criteria
Inclusion Criteria: Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis WHO Performance Status 0-2 No prior chemotherapy, biological or immunological therapy/surgery Exclusion Criteria: Any evidence of clinically active interstitial lung disease Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation Patients with previously diagnosed and treated CNS metastases or spinal cord compression
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gefitinib
Arm Description
Gefitinib 250mg tablet once daily
Outcomes
Primary Outcome Measures
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
RECIST criteria:
CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Secondary Outcome Measures
Progression Free Survival (PFS)
Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Overall Survival (OS)
Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
Safety Profile: Participants With Adverse Events
Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00344773
Brief Title
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
Official Title
An Open-label, Multi-centre Study to Evaluate Efficacy and Safety of Gefitinib as the First-line Treatment for Locally Advanced (IIIB), Metastatic (IV) or Recurrent Pulmonary Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Cancer
Keywords
Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation, Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation, Recurrent pulmonary adenocarcinoma with EGFR mutation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
46 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gefitinib
Arm Type
Experimental
Arm Description
Gefitinib 250mg tablet once daily
Intervention Type
Drug
Intervention Name(s)
Gefitinib
Other Intervention Name(s)
ZD1839, IRESSA
Intervention Description
250mg tablet oral tablet once daily
Primary Outcome Measure Information:
Title
Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.
Description
Objective Response Rate (ORR) is defined as participants who had complete response (CR) or partial response(PR) divided by the total number of patients.
RECIST criteria:
CR = disappearance of all target lesions PR = 30% decrease in the sum of the longest diameter of target lesions PD = 20% increase in the sum of the longest diameter of target lesions SD (stable disease) = small changes that do not meet above criteria
Time Frame
baseline to 12 months
Secondary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
Progression free survival calculated using Kaplan-Meier Product Limit. Median PFS was not able to be calculated because the rate of PFS was below 50% at the end of follow-up period. Therefore, PFS percentage at 4 months is provided.
Time Frame
baseline to 4 months
Title
Overall Survival (OS)
Description
Median Overal survival was not able to be calculated because the rate of OS was below 50% at the end of follow-up period. Therefore, OS percentage at 12 months is provided.
Time Frame
baseline to 12 months
Title
Safety Profile: Participants With Adverse Events
Description
Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.
Time Frame
baseline to end of study
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients require histological biopsy and paraffin block more than 5mg from the original tumour or metastatic site to perform EGFR mutational analysis
WHO Performance Status 0-2
No prior chemotherapy, biological or immunological therapy/surgery
Exclusion Criteria:
Any evidence of clinically active interstitial lung disease
Newly diagnosed CNS metastases that have not yet been definitively treated with surgery /radiation
Patients with previously diagnosed and treated CNS metastases or spinal cord compression
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HyeJong Yoo
Organizational Affiliation
AstraZeneca
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Seongnam-Si
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
20430469
Citation
Kim DW, Lee SH, Lee JS, Lee MA, Kang JH, Kim SY, Shin SW, Kim HK, Heo DS. A multicenter phase II study to evaluate the efficacy and safety of gefitinib as first-line treatment for Korean patients with advanced pulmonary adenocarcinoma harboring EGFR mutations. Lung Cancer. 2011 Jan;71(1):65-9. doi: 10.1016/j.lungcan.2010.04.005.
Results Reference
derived
Learn more about this trial
First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation
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