Gene and Protein Expression Patterns in Predicting Response to Cetuximab in Patients With Recurrent and/or Metastatic Head and Neck Cancer

Head and Neck Cancer Clinical Trial

Official title:

Molecular Signatures of HNSCC in Response to Targeted Therapies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898742
• Other study ID #: VICC HN 0715
• Secondary ID: P30CA068485VU-VI
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: March 29, 2013
• Start date: April 2007
• Est. completion date: June 2010

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 58
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Head and Neck Cancer
• Head and Neck Neoplasms

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center at Franklin	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		approximately three years from enrollment of first patient	No
Primary	Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients		upon colleciton of final patient data	No
Primary	Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival		upon collection of final patient data	No