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

NCT00898742 | Terminated

• 4 other identifiers: VICC HN 0715P30CA068485VU-VICC-HN-0715VU-VICC-070668
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Head and Neck Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

• Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients

  upon colleciton of final patient data

• Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival

  upon collection of final patient data

Study Arms (1)

head and neck cancer patients

Genetic: DNA and tissue microarray analysis; Genetic: reverse transcriptase-polymerase chain reaction; Other: mass spectrometry

Interventions

DNA and tissue microarray analysis GENETIC

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.

head and neck cancer patients

reverse transcriptase-polymerase chain reaction GENETIC

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.

head and neck cancer patients

mass spectrometry OTHER

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.

head and neck cancer patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

head and neck cancer patients

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center at Franklin

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck; Salivary Gland Neoplasms

Interventions

DNA; Tissue Array Analysis; Reverse Transcriptase Polymerase Chain Reaction; Mass Spectrometry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Mouth Neoplasms; Mouth Diseases; Stomatognathic Diseases; Salivary Gland Diseases

Intervention Hierarchy (Ancestors)

Nucleic Acids; Nucleic Acids, Nucleotides, and Nucleosides; Microarray Analysis; Microchip Analytical Procedures; Investigative Techniques; Polymerase Chain Reaction; Nucleic Acid Amplification Techniques; Genetic Techniques; Chemistry Techniques, Analytical

Study Officials

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Medical Oncologist

Study Record Dates

• First Submitted: May 9, 2009
• First Posted: May 12, 2009
• Study Start: April 1, 2007
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

US (3)