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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00897533
First Posted: May 12, 2009
Last Update Posted: May 19, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group )
  Purpose

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 Intervention
Lung Cancer Genetic: gene mapping Genetic: polymorphism analysis Other: diagnostic laboratory biomarker analysis Other: immunohistochemistry staining method

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Retrospective
Official Title: Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):

Primary Outcome Measures:
  • Mesenchymal and epithelial markers [ Time Frame: 1 month ]
    Mesenchymal and epithelial markers

  • 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

  • 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

  • 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


Enrollment: 137
Actual Study Start Date: April 13, 2007
Study Completion Date: April 13, 2008
Primary Completion Date: April 13, 2008 (Final data collection date for primary outcome measure)
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   up to 120 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Samples submitted for research from patients participating in E3503
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00897533


Sponsors and Collaborators
ECOG-ACRIN Cancer Research Group
National Cancer Institute (NCI)
Investigators
Study Chair: Jill Kolesar, PharmD University of Wisconsin, Madison
  More Information

Publications:
Responsible Party: ECOG-ACRIN Cancer Research Group
ClinicalTrials.gov Identifier: NCT00897533     History of Changes
Other Study ID Numbers: CDR0000543981
ECOG-E3503T1
First Submitted: May 9, 2009
First Posted: May 12, 2009
Last Update Posted: May 19, 2017
Last Verified: May 2017

Keywords provided by Eastern Cooperative Oncology Group ( ECOG-ACRIN Cancer Research Group ):
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

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Erlotinib Hydrochloride
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action