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NCT Number: NCT00897533

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

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.

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Key information

Conditions

Lung Cancer Adenocarcinoma Adenocarcinoma of Lung Adenocarcinoma, Bronchiolo-Alveolar Bronchial Neoplasms Carcinoma Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Respiratory Tract Diseases Respiratory Tract Neoplasms Thoracic Neoplasms

Age range

Up to 120 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gene mapping

Genetic

polymorphism analysis

Genetic

diagnostic laboratory biomarker analysis

Other

immunohistochemistry staining method

Other

Primary outcomes

  1. Mesenchymal and epithelial markers

    Time frame: 1 month

    Mesenchymal and epithelial markers

  2. Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)

    Time frame: 1 month

    Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers

  3. Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers

    Time frame: 1 month

    Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers

  4. Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

    Time frame: 1 month

    Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS

Sponsors and collaborators

Lead sponsor

ECOG-ACRIN Cancer Research Group

Network

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
May 12, 2009
Registry last updated
May 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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