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


N/A
N/A
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Open (Enrolling)
Both
Lung Cancer

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Trial Information

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


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.

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

Type of Study:

Observational

Study Design:

N/A

Outcome Measure:

Mesenchymal and epithelial markers

Safety Issue:

No

Principal Investigator

Jill Kolesar, PharmD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000543981

NCT ID:

NCT00897533

Start Date:

April 2007

Completion Date:

Related Keywords:

  • Lung Cancer
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms

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