Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer
NCT ID: NCT00898742
Last Updated: 2013-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
58 participants
OBSERVATIONAL
2007-04-30
2010-06-30
Brief Summary
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PURPOSE: This research study is looking at gene and protein expression patterns in predicting response to cetuximab in patients with recurrent and/or metastatic head and neck cancer.
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Detailed Description
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* To identify 100 patients from the Head and Neck Tumor Tissue Repository and Clinical Database treated with cetuximab monotherapy or cetuximab-containing combination therapy as a standard of care for recurrent and/or metastatic head and neck squamous cell carcinoma at Vanderbilt University Medical Center.
* To assay the diversity of gene and protein expression patterns seen in these patients.
* To identify predictive patterns associated with treatment response and survival of these patients by correlating the laboratory data with clinical data.
OUTLINE: Tumor tissue specimens and clinical data are obtained from the Head and Neck Tumor Tissue Repository and Clinical Database protocol VU-VICC-HN-0356. Specimens are analyzed for patterns of gene and protein expression predictive of cetuximab treatment response and survival by DNA microarray, tissue microarray, reverse transcriptase-PCR, and mass spectroscopy.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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head and neck cancer patients
DNA and tissue microarray analysis
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
reverse transcriptase-polymerase chain reaction
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
mass spectrometry
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
Interventions
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DNA and tissue microarray analysis
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
reverse transcriptase-polymerase chain reaction
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
mass spectrometry
The lab has a candidate gene expression signature for the prediction of the cetuximab response. It may be possible to identify patients who will respond to cetuximab based on the patterns of gene and protein expression.
Eligibility Criteria
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Inclusion Criteria
* Diagnosis of recurrent and/or metastatic head and neck squamous cell carcinoma
* Enrolled on the Head and Neck Tissue Repository and Clinical Database protocol VU-VICC-HN-0356
* Previously treated with cetuximab monotherapy or cetuximab-based combination therapy
* Sufficient biological material available for analysis
PATIENT CHARACTERISTICS:
* Not specified
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Barbara Murphy, MD
Professor of Medicine, Medical Oncologist
Principal Investigators
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Barbara Murphy, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-HN-0715
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-070668
Identifier Type: -
Identifier Source: secondary_id
VICC HN 0715
Identifier Type: -
Identifier Source: org_study_id
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