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Completed

NCT Number: NCT00344773

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

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

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Key information

Conditions

Pulmonary Cancer Lung Diseases Lung Neoplasms Neoplasm Metastasis Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Seongnam-si, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Gefitinib

Drug

250mg tablet oral tablet once daily

Other names: ZD1839, IRESSA

Primary outcomes

  1. Percentage of Participants Who Had an Objective Response Rate(ORR) Based on Response Evaluation Criteria In Solid Tumors (RECIST) Criteria.

    Time frame: baseline to 12 months

    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 outcomes

  1. Progression Free Survival (PFS)

    Time frame: baseline to 4 months

    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.

  2. Overall Survival (OS)

    Time frame: baseline to 12 months

    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.

  3. Safety Profile: Participants With Adverse Events

    Time frame: baseline to end of study

    Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jun 27, 2006
Registry last updated
Jun 29, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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