Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507

Case Comprehensive Cancer Center (Case CCC)

Status: Withdrawn

Conditions: Lung Cancer

Treatments: Other: laboratory biomarker analysis; Genetic: reverse transcriptase-polymerase chain reaction; Genetic: DNA analysis; Genetic: RNA analysis; Genetic: gene expression analysis; Genetic: fluorescence in situ hybridization; Genetic: polymerase chain reaction; Genetic: mutation analysis

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00907699

P30CA043703 (U.S. NIH Grant/Contract)

CASE9507 (Other Identifier)

Details and patient eligibility

About

RATIONALE: Studying samples of blood and tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and RNA and identify biomarkers related to cancer.

PURPOSE: This laboratory study is looking at biomarkers in tumor tissue and blood samples from patients with non-small cell lung cancer.

Full description

OBJECTIVES:

Primary

• Identify mutations in epidermal growth factor receptor (EGFR) in non-small cell lung cancer specimens from clinical trial CASE-2507.
• Investigate EGFR DNA copy-number changes.
• Determine abnormalities of other pathways, such as the c-MET and PI3K pathways as potential mechanisms of resistance.

OUTLINE: This is a multicenter study.

DNA and RNA are extracted from tumor samples. Genomic DNA is analyzed using real-time PCR/ reverse transcriptase PCR analysis and/or FISH analysis in order to study resistance mechanisms such as secondary EGFR mutations and the c-MET and PI3K pathways. RNA is analyzed using TaqMan quantitative PCR in order to determine the copy number of EGFR expressed in these tissues. Peripheral blood samples are used to isolate peripheral blood mononuclear cells positive for epithelial cell adhesion molecule (EpCAM).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

DISEASE CHARACTERISTICS:

• Eligible for and concurrently enrolled on clinical trial CASE-2507

PATIENT CHARACTERISTICS:

• Willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
• Normal coagulation profile and platelet count > 100,000/mm³*
• Not pregnant NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No concurrent anticoagulants (e.g., warfarin or low-molecular weight heparin)
• No concurrent antiplatelet therapy (e.g., aspirin, clopidogrel, or other antiplatelet agents)* NOTE: *For patients who have not had a second biopsy procedure already at the time of progression on erlotinib hydrochloride therapy and require a research biopsy.