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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2007 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00897533
First received: May 9, 2009
Last updated: June 21, 2011
Last verified: June 2007
  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
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 National Cancer Institute (NCI):

Primary Outcome Measures:
  • Mesenchymal and epithelial markers [ Designated as safety issue: No ]
  • Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression) [ Designated as safety issue: No ]
  • Prediction of progression-free survival (PFS) by mesenchymal and epithelial markers [ Designated as safety issue: No ]
  • Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS [ Designated as safety issue: No ]

Estimated Enrollment: 137
Study Start Date: April 2007
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00897533

Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Jill Kolesar, PharmD University of Wisconsin, Madison
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00897533     History of Changes
Other Study ID Numbers: CDR0000543981, ECOG-E3503T1
Study First Received: May 9, 2009
Last Updated: June 21, 2011
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Erlotinib
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 26, 2014