First-line Treatment for Adenocarcinoma Patients With Epidermal Growth Factor Receptor (EGFR) Mutation

Pulmonary Cancer Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00344773
• Other study ID #: D7913L00056
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2006
• Last updated: June 24, 2010
• Start date: March 2006
• Est. completion date: December 2007

Study information

• Verified date: June 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the overall objective tumor response rate (ORR) of Gefitinib.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Pulmonary Cancer

Intervention

Drug:
• Gefitinib
250mg tablet oral tablet once daily

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Seongnam-Si
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	baseline to 12 months	No
Secondary	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.	baseline to 4 months	No
Secondary	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.	baseline to 12 months	No
Secondary	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.	baseline to end of study	Yes