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

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 58 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Head and Neck Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2009-05-12
• Last updated: 2013-04-02

Locations

3 sites across 1 country: United States