A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib

December 10, 2013 updated by: National University Hospital, Singapore

We hypothesize that Epidermal growth factor receptor tyrosine kinase inhibitors modulate tumor changes that may be reflected in the alteration of serum proteins.

Study objectives are:

  • To establish serum proteomic changes in patients with non-small cell lung cancer (NSCLC) receiving erlotinib or gefitinib.
  • To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
  • To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

Although some success has been achieved in identifying Epidermal growth factor receptor (EGFR) mutations as a molecular predictive marker of response in patients with non-small cell lung cancer (NSCLC), this strategy is likely only to be limited as not all responding patients have a mutation in their tumor and conversely, not all patients with a mutation were responders. Furthermore, as the development of resistance to EGFR tyrosine kinase inhibitors (TKI) such as gefitinib, erlotinib is inevitable and poses a major clinical problem due to limited therapeutic options, the identification of a molecular profile that could predict sensitivity to erlotinib or gefitinib is warranted.

Hypothesis:

Using serum as an easily accessible biological fluid, we hypothesize that EGFR TKIs modulate tumor changes that may be reflected in the alteration of serum proteins.

Objectives:

  • To establish the serum proteomic changes in NSCLC patients receiving erlotinib or gefitinib.
  • To identify a serum protein profile that predicts erlotinib or gefitinib sensitivity or resistance in NSCLC patients with and without EGFR mutations.
  • To study the toxicity of erlotinib or gefitinib by correlating clinical toxicity with serum protein profile.

Significance:

An extensive profiling of the molecular circuitry affected by EGFR TKIs would be helpful in understanding the response and side effects of patients with NSCLC treated with erlotinib or gefitinib and could guide therapy and thus improve patient outcome.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore
        • National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Any patient with NSCLC receiving erlotinib or gefitinib. Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

Description

Inclusion Criteria:

  • Any patient with NSCLC receiving erlotinib or gefitinib.
  • Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.
  • Age ≥ 18 years
  • Written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
1
Any patient with NSCLC receiving erlotinib or gefitinib
2
Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2006

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 17, 2008

First Posted (Estimate)

July 18, 2008

Study Record Updates

Last Update Posted (Estimate)

December 11, 2013

Last Update Submitted That Met QC Criteria

December 10, 2013

Last Verified

December 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NS01/19/05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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