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

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00344773
First received: June 26, 2006
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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


Condition Intervention Phase
Pulmonary Cancer
Drug: Gefitinib
Phase 2

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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    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) [ Time Frame: baseline to 4 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: baseline to end of study ] [ Designated as safety issue: Yes ]
    Safety profile as defined by adverse events and serious adverse events throughtout the study period. Details listed in the SAE and Other AE section.


Enrollment: 46
Study Start Date: March 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gefitinib
Gefitinib 250mg tablet once daily
Drug: Gefitinib
250mg tablet oral tablet once daily
Other Names:
  • ZD1839
  • IRESSA

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00344773

Locations
Korea, Republic of
Research Site
Seongnam-Si, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: HyeJong Yoo AstraZeneca
  More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00344773     History of Changes
Other Study ID Numbers: D7913L00056
Study First Received: June 26, 2006
Results First Received: December 19, 2008
Last Updated: June 24, 2010
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Locally advanced (IIIB) pulmonary adenocarcinoma with EGFR mutation
Metastatic (IV) pulmonary adenocarcinoma with EGFR mutation
Recurrent pulmonary adenocarcinoma with EGFR mutation

Additional relevant MeSH terms:
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Mitogens
Gefitinib
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on September 18, 2014