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

This study has been completed.
Sponsor:
Information provided by:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00717847
First received: July 17, 2008
Last updated: December 10, 2013
Last verified: December 2013
  Purpose

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.

Condition
Non Small Cell Lung Cancer

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Study of Serum Protein Profiling in Patients With Non-Small Cell Lung Cancer Treated With Gefitinib or Erlotinib

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Study Start Date: February 2006
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Any patient with NSCLC receiving erlotinib or gefitinib
2
Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00717847

Locations
Singapore
National University Hospital
Singapore, Singapore
Sponsors and Collaborators
National University Hospital, Singapore
Investigators
Principal Investigator: Ross Andrew Soo, MBBS National University Hospital, Singapore
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00717847     History of Changes
Other Study ID Numbers: NS01/19/05
Study First Received: July 17, 2008
Last Updated: December 10, 2013
Health Authority: Singapore: Domain Specific Review Boards

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
Gefitinib
Erlotinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 17, 2014