- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00898742
Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Molecular Signatures of HNSCC in Response to Targeted Therapies
RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how will patients respond to treatment.
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.
Study Overview
Status
Conditions
Detailed Description
OBJECTIVES:
- 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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center at Franklin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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head and neck cancer patients
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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.
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.
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Identification of 100 patients from the Head and Neck (H&N) Tumor Tissue Repository and Clinical Database treated with cetuximab or cetuximab-containing combination therapy as a standard of care
Time Frame: approximately three years from enrollment of first patient
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approximately three years from enrollment of first patient
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Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients
Time Frame: upon colleciton of final patient data
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upon colleciton of final patient data
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Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival
Time Frame: upon collection of final patient data
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upon collection of final patient data
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- recurrent metastatic squamous neck cancer with occult primary
- metastatic squamous neck cancer with occult primary squamous cell carcinoma
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage IV verrucous carcinoma of the oral cavity
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent verrucous carcinoma of the oral cavity
- stage IV squamous cell carcinoma of the oropharynx
- recurrent squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the nasopharynx
- recurrent squamous cell carcinoma of the nasopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the larynx
- stage IV verrucous carcinoma of the larynx
- recurrent squamous cell carcinoma of the larynx
- recurrent verrucous carcinoma of the larynx
- stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity
- recurrent salivary gland cancer
- stage IV salivary gland cancer
- salivary gland squamous cell carcinoma
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC HN 0715
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-HN-0715
- VU-VICC-070668
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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