Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer

Sponsor

ECOG-ACRIN Cancer Research Group (Other)

Overall Status

Completed

CT.gov ID

NCT00897533

Collaborator

National Cancer Institute (NCI) (NIH)

137

Enrollment

Actual Duration (Months)

Study Details

Study Description

Brief Summary

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients respond to treatment with erlotinib.

PURPOSE: This laboratory study is developing a model to predict progression-free survival after erlotinib in patients with non-small cell lung cancer.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer	Genetic: gene mapping Genetic: polymorphism analysis Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method

Detailed Description

OBJECTIVES:

Assess mesenchymal and epithelial markers in tissues from patients with non-small cell lung cancer treated with erlotinib hydrochloride on clinical trial ECOG-E3503.
Determine the loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) in these patients.
Assess whether mesenchymal and epithelial markers are predictive of progression-free survival (PFS) of these patients.
Identify a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS of these patients.

OUTLINE: Tissue samples are analyzed by whole genome mapping for single nucleotide polymorphism (SNP) rate and by signal detection rate and by quantitative immunohistochemistry for mesenchymal (vimentin/cytokeratin) and epithelial (E-cadherin) marker transitions. After biomarker identification and gene mapping are complete, a model to predict progression-free survival in these patients is developed.

PROJECTED ACCRUAL: A total of 137 samples will be accrued for this study.

Study Design

Study Type:

Observational

Actual Enrollment :

137 participants

Observational Model:

Other

Time Perspective:

Retrospective

Official Title:

Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503

Actual Study Start Date :

Apr 13, 2007

Actual Primary Completion Date :

Apr 13, 2008

Actual Study Completion Date :

Apr 13, 2008

Outcome Measures

Primary Outcome Measures

Mesenchymal and epithelial markers [1 month]
Mesenchymal and epithelial markers
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) [1 month]
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers [1 month]
Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS [1 month]
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

DISEASE CHARACTERISTICS:

Diagnosis of non-small cell lung cancer, including any of the following subtypes:
Adenocarcinoma
Squamous cell carcinoma
Bronchoalveolar carcinoma
Carcinoid
Stage IIIB or IV or recurrent disease
Must have received treatment with erlotinib hydrochloride on clinical trial ECOG-E3503