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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00897533

Enrollment

137

Registered

2009-05-12

Start date

2007-04-13

Completion date

2008-04-13

Last updated

2017-05-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer, adenocarcinoma of the lung, squamous cell lung cancer, bronchoalveolar cell lung cancer

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.

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.

Interventions

GENETICgene mapping

GENETICpolymorphism analysis

OTHERdiagnostic laboratory biomarker analysis

OTHERimmunohistochemistry staining method

Study design

Observational model

OTHER

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

No minimum to 120 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026