Clinical trial NCT00897533: Development of a Model to Predict Progression-Free Survival After Erlotinib in Patients With Non-Small Cell Lung Cancer
Official title: Development of a Model to Predict Progression Free Survival After Treatment With Erlotinib in E3503
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 137
Sex: ALL
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients participating in E3503

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.

Eligibility 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

Primary outcomes:
measure: Mesenchymal and epithelial markers
timeFrame: 1 month
measure: Loss of epithelial markers (E-cadherin) and gain of mesenchymal markers (vimentin/cytokeratin co-expression)
timeFrame: 1 month
measure: Correlation of progression-free survival (PFS) by mesenchymal and epithelial markers
timeFrame: 1 month
measure: Identification of a single nucleotide polymorphism profile via whole genome mapping and other known biomarkers to predict PFS
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Jill Kolesar, PharmD
role: STUDY_CHAIR
References:
citation: Amann JM, Lee JW, Roder H, Brahmer J, Gonzalez A, Schiller JH, Carbone DP. Genetic and proteomic features associated with survival after treatment with erlotinib in first-line therapy of non-small cell lung cancer in Eastern Cooperative Oncology Group 3503. J Thorac Oncol. 2010 Feb;5(2):169-78. doi: 10.1097/JTO.0b013e3181c8cbd9.