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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Head and Neck Cancer

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00898742

VU-VICC-HN-0715

VU-VICC-070668

P30CA068485 (U.S. NIH Grant/Contract)

VICC HN 0715

Details and patient eligibility

About

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.

Full 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.

Enrollment: 58 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

58 participants in 1 patient group

head and neck cancer patients

Treatment:

Genetic: reverse transcriptase-polymerase chain reaction

Genetic: DNA and tissue microarray analysis

Other: mass spectrometry