Clinical trial NCT00896675: Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
Official title: Proteomic Prediction of Clinical Benefit in HNSCC
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Head and Neck Cancer
Keywords: 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
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 352
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and Neck cancer patients

Brief summary: RATIONALE: Studying samples of blood in the laboratory may help doctors learn more about cancer. It may also help doctors predict how well patients will respond to treatment.

PURPOSE: This research study is looking at proteins in blood samples to predict treatment benefit in patients with recurrent and/or metastatic squamous cell head and neck cancer.

Detailed description: 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.

Eligibility 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

Primary outcomes:
measure: Identification of patients who will benefit from treatment with EGFR and/or VEGF inhibitors based on serum proteomic profiles
timeFrame: upon analysis of each patient tissue collection
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center at Franklin
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Barbara Murphy, MD
role: STUDY_CHAIR
References: