Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2008 by Aarhus University Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Hoffmann-La Roche
Information provided by:
Aarhus University Hospital
ClinicalTrials.gov Identifier:
NCT00815971
First received: December 30, 2008
Last updated: NA
Last verified: December 2008
History: No changes posted
  Purpose

Recently it has been suggested that specific mutations in the EGFR gene in lung cancer patients is associated with response to a novel drug targeting the EGF system. Recent research also indicates that there is a possible association to the degree of aggressiveness of the disease.

The importance of these mutations is controversial, because the data are based on small studies with highly selected patients.

In this project the investigators want to study the types and frequencies of EGFR mutations in both untreated and treated patients in a systematic manner and relate this to survival.

The thorough registration of patient data in DK enables us to create a strong The investigators expect this knowledge to be of greatest importance for future rational use of drugs targeting the EGF receptors.


Condition
Non-Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Mutations in the Epidermal Growth Factor Receptor(EGFR) Gene in Non-Small Cell Lung Carcinoma (NSCLC) and the Relation to Response of Treatment With Erlotinib

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital:

Primary Outcome Measures:
  • overall survival [ Time Frame: 1 year after the last patient is enrolled ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • response( according to RECIST) [ Time Frame: 3 month after the last patient is enrolled ] [ Designated as safety issue: No ]
  • quality of live ( measured by EORTC PAL 15) [ Time Frame: 3 month after the last patient is enrolled ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

a fine neddle biopsi taken when the diagnosis non-small cell lung carcinoma was made + severals blood samples taken before and during treatment with erlotinib.


Estimated Enrollment: 300
Study Start Date: May 2008
Estimated Study Completion Date: May 2011
Estimated Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
NSCLC
Patients with non-small cell lung cancer carcinoma treated with erlotinib

Detailed Description:

Aim:

  1. To establish a method for identifying the mutations in the EGFR gene in small clinical samples from lung cancer patients.
  2. In a retrospective study(n=500) relate survival to the frequency and types of mutations in the EGFR gene in a Danish population of patients with advanced, inoperable non small cell lung cancer (NSCLC) diagnosed prior to the introduction of treatment directed towards EGFR.
  3. In a prospective study (n=300), to identify the mutations in the EGFR gene in patients treated with erlotinib, a tyrosine kinase inhibitor targeting the EGFR. Presence of mutations will be related to the expression of other parts of the EGF system, to mutations in the gene coding for K-RAS and to treatment response.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with non-small cell lung cancer who will start treatment with erlotinib

Criteria

Inclusion Criteria:

  • Patients who are starting treatment with erlotinib and who has who has signed the informed consent.

Exclusion Criteria:

  • None
  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: NCT00815971

Contacts
Contact: Britta Weber, MD +4589493333 doctorweber@stofanet.dk
Contact: Peter Meldgaard, PhD MD +4589493333 peter.meldgaard@dadnnet.dk

Locations
Denmark
department of oncology, University Hospital of Aarhus, Nørrebrogade 44 Recruiting
8000 Aarhus, Denmark
Contact: Britta Weber, MD    +4589493333    doctorweber@stofanet.dk   
Contact: Peter meldgaard, PhD MD    +4589493333    peter.meldgaard@dadlnet.dk   
Principal Investigator: Peter meldgaard, PhD MD         
Sponsors and Collaborators
Aarhus University Hospital
University of Aarhus
The Ministry of Science, Technology and Innovation, Denmark
Hoffmann-La Roche
Investigators
Principal Investigator: Peter Meldgaard, PhD MD Aarhus University Hospital
  More Information

No publications provided by Aarhus University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: PhD, MD Peter Meldgaard and MD Britta Weber, Aarhus University Hospital
ClinicalTrials.gov Identifier: NCT00815971     History of Changes
Other Study ID Numbers: M-20080012 (ethics committee)
Study First Received: December 30, 2008
Last Updated: December 30, 2008
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics
Denmark: Danish Dataprotection Agency

Keywords provided by Aarhus University Hospital:
EGFR mutations
EGFR inhibitor
erlotinib

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Mitogens
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Mitosis Modulators

ClinicalTrials.gov processed this record on September 16, 2014