Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer
This study has been terminated.
(study closed prematurely upon PI's departure from VICC)
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00898742
First received: May 9, 2009
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Genetic: DNA and tissue microarray analysis Genetic: reverse transcriptase-polymerase chain reaction Other: mass spectrometry |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Molecular Signatures of HNSCC in Response to Targeted Therapies |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients [ Time Frame: upon colleciton of final patient data ] [ Designated as safety issue: No ]
- Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival [ Time Frame: upon collection of final patient data ] [ Designated as safety issue: No ]
| Enrollment: | 58 |
| Study Start Date: | April 2007 |
| Study Completion Date: | June 2010 |
| Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| head and neck cancer patients |
Genetic: 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.
Genetic: 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.
Other: 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.
|
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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
head and neck cancer patients
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00898742
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00898742 History of Changes |
| Other Study ID Numbers: | VICC HN 0715, P30CA068485, VU-VICC-HN-0715, VU-VICC-070668 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
recurrent squamous cell carcinoma of the hypopharynx stage IV 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 recurrent squamous cell carcinoma of the lip and oral cavity stage IV squamous cell carcinoma of the lip and oral cavity recurrent verrucous carcinoma of the oral cavity stage IV verrucous carcinoma of the oral cavity metastatic squamous neck cancer with occult primary squamous cell carcinoma |
recurrent metastatic squamous neck cancer with occult primary recurrent squamous cell carcinoma of the nasopharynx stage IV squamous cell carcinoma of the nasopharynx recurrent squamous cell carcinoma of the oropharynx stage IV squamous cell carcinoma of the oropharynx recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity recurrent salivary gland cancer salivary gland squamous cell carcinoma stage IV salivary gland cancer |
Additional relevant MeSH terms:
|
Head and Neck Neoplasms Neoplasms by Site Neoplasms Cetuximab |
Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013