Biomarkers Predicting Response in Patients With Non-Small Cell Lung Cancer Previously Treated With Erlotinib Hydrochloride

May 16, 2017 updated by: ECOG-ACRIN Cancer Research Group

Measurement of Potential Biomarkers Predicting Erlotinib Response

RATIONALE: Studying samples of blood in the laboratory from patients receiving erlotinib hydrochloride may help doctors learn more about the effects of erlotinib hydrochloride on cells. It may also help doctors understand how well patients respond to treatment.

PURPOSE: This research study is studying biomarkers predicting response in patients with non-small cell lung cancer previously treated with erlotinib hydrochloride.

Study Overview

Status

Completed

Conditions

Lung Cancer

Intervention / Treatment

Detailed Description

OBJECTIVES:

To evaluate whether serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin can be utilized as biomarkers to predict response in patients with non-small cell lung cancer treated with erlotinib hydrochloride.

OUTLINE: Serum samples are analyzed for NGAL, MMP-9, NGAL/MMP-9, and soluble E-cadherin by ELISA and Luminex assays.

Study Type

Observational

Enrollment (Actual)

127

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 to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Samples submitted for research from patients enrolled on E3503

Description

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer
Received erlotinib hydrochloride on clinical trial ECOG-E3503

PATIENT CHARACTERISTICS:

Not specified

PRIOR CONCURRENT THERAPY:

See Disease Characteristics

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Baseline serum NGAL, MMP-9, NGAL/MMP-9 complex, and soluble E-cadherin levels as predictors of erlotinib hydrochloride response Time Frame: 1 month	1 month

Collaborators and Investigators

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

Sponsor

ECOG-ACRIN Cancer Research Group

Collaborators

National Cancer Institute (NCI)

Investigators

Principal Investigator: Steven M. Dubinett, MD, Jonsson Comprehensive Cancer Center

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 (ACTUAL)

April 12, 2010

Primary Completion (ACTUAL)

June 12, 2010

Study Completion (ACTUAL)

June 12, 2010

Study Registration Dates

First Submitted

May 13, 2010

First Submitted That Met QC Criteria