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

Phase 2CompletedNCT00344773

AstraZeneca46 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Pulmonary Cancer

Interventions

GefitinibDRUG

250mg tablet oral tablet once daily

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (2)

Research Site

Seongnam-si, South Korea

Research Site

Seoul, South Korea

Outcomes

Primary Outcomes

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

Time frame: baseline to 12 months

Secondary Outcomes

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.

Time frame: baseline to 4 months

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.

Time frame: baseline to 12 months

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.

Time frame: baseline to end of study

Data from ClinicalTrials.gov

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