Clinical trial NCT00907699: Laboratory Study Using Samples From Patients With Non-Small Cell Lung Cancer Treated on Clinical Trial CASE-2507
Official title: 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
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Primary Care Clinic

Brief summary: 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.

Detailed 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).

Eligibility 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.

Primary outcomes:
measure: Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS)
timeFrame: At the time of the second biopsy or surgical procedures
measure: Difference of PFS between those with and without T790M mutation
timeFrame: At the time of the second biopsy or surgical procedures
measure: Difference of clinical response rate between T790M mutation statuses
timeFrame: At the time of the second biopsy or surgical procedures
measure: Predictive value of mutation status on clinical response
timeFrame: At the time of the second biopsy or surgical procedures
measure: Association between T790M mutation and baseline clinical-pathological factors and smoking status
timeFrame: At the time of the second biopsy or surgical procedures
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
name: Afshin Dowlati, MD
role: PRINCIPAL_INVESTIGATOR
References: