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Study of Epithelial Growth Factor Receptor Mutations in Tumor Specimens and Blood Samples From Patients With Non-Small Cell Lung Cancer Enrolled on Clinical Trial CASE-2507


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

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Trial Information

Study of Epithelial Growth Factor Receptor Mutations in Tumor Specimens and Blood Samples From Patients With Non-Small Cell Lung Cancer Enrolled on Clinical Trial CASE-2507


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).

Inclusion 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.

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Outcome Measure:

Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS)

Outcome Time Frame:

At the time of the second biopsy or surgical procedures

Safety Issue:

No

Principal Investigator

Afshin Dowlati, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

CASE9507

NCT ID:

NCT00907699

Start Date:

August 2008

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

Name

Location
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center Cleveland, Ohio  44106-5065