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

Sponsors and Collaborators:	Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00898742

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 analysis Genetic: microarray analysis Genetic: protein expression analysis Genetic: proteomic profiling Genetic: reverse transcriptase-polymerase chain reaction Other: mass spectrometry

Study Type:	Observational
Official Title:	Molecular Signatures of HNSCC in Response to Targeted Therapies

Resource links provided by NLM:

MedlinePlus related topics: Cancer Head and Neck Cancer Salivary Gland Disorders

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

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 [ Designated as safety issue: No ]
Gene and protein expression patterns in selected H&N Tumor Tissue Repository and Clinical Database patients [ Designated as safety issue: No ]
Predictive patterns of gene and protein expression associated with cetuximab treatment response and survival [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	April 2007
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

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

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	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Christine Chung 615-936-3457
Vanderbilt-Ingram Cancer Center at Franklin	Recruiting
Nashville, Tennessee, United States, 37064
Contact: Christine Chung 615-936-3457
Vanderbilt-Ingram Cancer Center	Recruiting
Nashville, Tennessee, United States, 37232-6838
Contact: Clinical Trials Office - Vanderbilt-Ingram Cancer Center 800-811-8480

Sponsors and Collaborators

Vanderbilt-Ingram Cancer Center

National Cancer Institute (NCI)

Investigators

Study Chair:

Christine Chung, MD

Vanderbilt-Ingram Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000583148, VU-VICC-HN-0715, VU-VICC-070668
Study First Received:	May 9, 2009
Last Updated:	August 11, 2009
ClinicalTrials.gov Identifier:	NCT00898742 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Nasopharyngeal Carcinoma
Laryngeal Carcinoma
Cetuximab
Carcinoma, Squamous Cell of Head and Neck
Squamous Cell Carcinoma
Recurrence
Carcinoma

Hypopharyngeal Cancer
Metastatic Squamous Neck Cancer With Occult Primary
Head and Neck Neoplasms
Epidermoid Carcinoma
Carcinoma, Squamous Cell
Salivary Gland Diseases

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Head and Neck Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009