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Proteomic Prediction of Clinical Benefit in HNSCC


N/A
N/A
N/A
Not Enrolling
Both
Head and Neck Cancer

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Trial Information

Proteomic Prediction of Clinical Benefit in HNSCC


OBJECTIVES:

- To identify head and neck squamous cell cancer patients who will benefit from treatment
with the EGFR inhibitors (i.e., erlotinib hydrochloride, gefitinib, and cetuximab) and
VEGF inhibitor (i.e., bevacizumab), based on predictive proteomic profiles in patient
blood samples.

OUTLINE: This is a multicenter study.

Blood samples are analyzed for proteomic profile to determine good and bad prognoses in
patients treated with or without EGFR inhibitors and/or a VEGF inhibitor.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Diagnosis of squamous cell head and neck cancer

- Recurrent and/or metastatic disease

- Meets 1 of the following criteria:

- Previously treated with EGFR inhibitors and/or VEGF inhibitor on 1 of the
following clinical trials, and has available blood samples:

- A Phase I/II Study of Bevacizumab (rhu MAb VEGF) in Combination With
OSI-774 for Patients With Recurrent or Metastatic Cancer of the Head and
Neck

- A Phase II Study of 250-mg ZD1839 Monotherapy in Recurrent or Metastatic or
Both Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

- Previously treated with cetuximab and has blood samples available from protocol
VU-VICC-HN-0356

- Previously treated with conventional chemotherapy and has blood samples
available from protocol VU-VICC-HN-0356

PATIENT CHARACTERISTICS:

- Not specified

PRIOR CONCURRENT THERAPY:

- See Disease Characteristics

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Retrospective

Outcome Measure:

Identification of patients who will benefit from treatment with EGFR and/or VEGF inhibitors based on serum proteomic profiles

Outcome Time Frame:

upon analysis of each patient tissue collection

Safety Issue:

No

Principal Investigator

Barbara Murphy, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Vanderbilt-Ingram Cancer Center

Authority:

United States: Federal Government

Study ID:

VICC HN 0744

NCT ID:

NCT00896675

Start Date:

June 2007

Completion Date:

December 2009

Related Keywords:

  • Head and Neck Cancer
  • recurrent squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • recurrent squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • recurrent squamous cell carcinoma of the lip and 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
  • salivary gland squamous cell carcinoma
  • stage IV salivary gland cancer
  • recurrent salivary gland cancer
  • Neoplasms, Squamous Cell
  • Head and Neck Neoplasms

Name

Location
Vanderbilt-Ingram Cancer Center Nashville, Tennessee  37232-6838
Vanderbilt-Ingram Cancer Center - Cool Springs Nashville, Tennessee  37064
Vanderbilt-Ingram Cancer Center at Franklin Nashville, Tennessee  37064