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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2007-12-31

Brief Summary

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

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Detailed Description

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Conditions

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Pulmonary Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gefitinib

Gefitinib 250mg tablet once daily

Group Type EXPERIMENTAL

Gefitinib

Intervention Type DRUG

250mg tablet oral tablet once daily

Interventions

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Gefitinib

250mg tablet oral tablet once daily

Intervention Type DRUG

Other Intervention Names

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ZD1839 IRESSA

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No