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

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ClinicalTrials.gov Identifier: NCT00907699
Recruitment Status : Withdrawn (Slow Accrual)
First Posted : May 22, 2009
Last Update Posted : July 24, 2014
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Study Description
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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.


Condition or disease Intervention/treatment
Lung Cancer Genetic: DNA analysis Genetic: RNA analysis Genetic: fluorescence in situ hybridization Genetic: gene expression analysis Genetic: mutation analysis Genetic: polymerase chain reaction Genetic: reverse transcriptase-polymerase chain reaction Other: laboratory biomarker analysis

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).

Study Design
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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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 Start Date : August 2008
Actual Primary Completion Date : February 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Intervention Details:
  • Genetic: DNA analysis
    DNA is 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.
  • Genetic: RNA analysis
    RNA is extracted from tumor samples. 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).
  • Genetic: fluorescence in situ hybridization
    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).
  • Genetic: gene expression analysis
    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).
  • Genetic: mutation analysis
    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).
  • Genetic: polymerase chain reaction
    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).
  • Genetic: reverse transcriptase-polymerase chain reaction
    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).
  • Other: laboratory biomarker analysis
    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).

Outcome Measures
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Primary Outcome Measures :
  1. Predictive value of T790M mutation status of the second biopsy (before maintenance therapy on CASE-2507) on progression-free survival (PFS) [ Time Frame: At the time of the second biopsy or surgical procedures ]
  2. Difference of PFS between those with and without T790M mutation [ Time Frame: At the time of the second biopsy or surgical procedures ]
  3. Difference of clinical response rate between T790M mutation statuses [ Time Frame: At the time of the second biopsy or surgical procedures ]
  4. Predictive value of mutation status on clinical response [ Time Frame: At the time of the second biopsy or surgical procedures ]
  5. Association between T790M mutation and baseline clinical-pathological factors and smoking status [ Time Frame: At the time of the second biopsy or surgical procedures ]

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

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Primary Care Clinic
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00907699


Sponsors and Collaborators
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Afshin Dowlati, MD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
More Information
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00907699    
Other Study ID Numbers: CASE9507
P30CA043703 ( U.S. NIH Grant/Contract )
CASE9507 ( Other Identifier: Case Comprehensive Cancer Center )
First Posted: May 22, 2009    Key Record Dates
Last Update Posted: July 24, 2014
Last Verified: July 2014
Keywords provided by Case Comprehensive Cancer Center:
recurrent non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
 Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms