Overview

This trial is active, not recruiting.

Condition lung cancer
Treatments gene mapping, polymorphism analysis, diagnostic laboratory biomarker analysis, immunohistochemistry staining method
Sponsor Eastern Cooperative Oncology Group
Collaborator National Cancer Institute (NCI)
Start date April 2007
Trial size 137 participants
Trial identifier NCT00897533, CDR0000543981, ECOG-E3503T1

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.

United States No locations recruiting
Other Countries No locations recruiting

Primary Outcomes

Measure
Mesenchymal and epithelial markers
time frame:
Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)
time frame:
Prediction of progression-free survival (PFS) by mesenchymal and epithelial markers
time frame:
Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
time frame:

Eligibility Criteria

Male or female participants of any age.

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 PATIENT CHARACTERISTICS: - Not specified PRIOR CONCURRENT THERAPY: - See Disease Characteristics

Additional Information

Official title Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503
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.
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).