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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2006-02-28

Study Completion Date

2013-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Non Small Cell Lung Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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1

Any patient with NSCLC receiving erlotinib or gefitinib

No interventions assigned to this group

2

Patients with unexpected and/or severe treatment related toxicity whilst receiving EGFR TKI.

No interventions assigned to this group

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Principal Investigators

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Ross Andrew Soo, MBBS

Role: PRINCIPAL_INVESTIGATOR

National University Hospital, Singapore

Locations

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National University Hospital

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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NS01/19/05

Identifier Type: -

Identifier Source: org_study_id