Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

NCT00898430 | Terminated DMC

• 4 other identifiers: VICC HN 0392P30CA068485VU-VICC-HN-0392VU-VICC-030933
• Study Type: observational
• Target: 49
• 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 patients will respond to treatment. PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.

Conditions

Head and Neck Cancer

Keywords

stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; stage III verrucous carcinoma of the oral cavity; stage IV verrucous carcinoma of the oral cavity; metastatic squamous neck cancer with occult primary squamous cell carcinoma; untreated metastatic squamous neck cancer with occult primary; stage III squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; salivary gland squamous cell carcinoma; stage III salivary gland cancer; stage IV salivary gland cancer

Outcome Measures

Primary Outcomes (1)

• Survival

  at expiration of last patient enrolled

Secondary Outcomes (1)

• Treatment response

  upon patient tissue collection

Study Arms (1)

Head and neck squamous cell carcinoma patients (HNSCC)

Genetic: DNA Microarray analysis; Genetic: MALDI-TOF mass spectrometry; Genetic: DNA microarray and MALDI-TOF mass spectrometry

Interventions

DNA Microarray analysis GENETIC

Tumors will be assayed on Affymetrix Human Genome U133 GeneChip

Head and neck squamous cell carcinoma patients (HNSCC)

MALDI-TOF mass spectrometry GENETIC

Supervised analysis techniques will be employed to identify patterns of protein peaks useful for treatment response and survival prediction. Hierarchical clustering analyses will be used to visualize data.

Head and neck squamous cell carcinoma patients (HNSCC)

DNA microarray and MALDI-TOF mass spectrometry GENETIC

Tumors from the specific Aim 1/2 and from preliminary data, previously analyzed, will be examined for HPV 16 infection.

Head and neck squamous cell carcinoma patients (HNSCC)

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 who are uniformly treated with concurrent carboplatin/paclitaxel and radiation.

DISEASE CHARACTERISTICS: * Newly diagnosed head and neck squamous cell carcinoma * Stage III-IV disease * Scheduled for pan-endoscopy * Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356 PATIENT CHARACTERISTICS: * Able to speak English 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

Oligonucleotide Array Sequence Analysis

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 Acid Hybridization; Genetic Techniques; Investigative Techniques; Sequence Analysis; Microarray Analysis; Microchip Analytical Procedures; Molecular Probe Techniques

Study Officials

• Barbara Murphy, MD

  Vanderbilt-Ingram Cancer Center

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• 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: November 1, 2003
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: April 2, 2013

Record last verified: 2013-03

Locations

US (3)