Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
NCT ID: NCT00896675
Last Updated: 2013-04-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
352 participants
OBSERVATIONAL
2007-06-30
2009-12-31
Brief Summary
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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.
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Detailed Description
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* 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.
Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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patients treated with EGFR inhibitors and/or VEGF inhibitor
proteomic profiles
blood samples analysis
NOT treated with EGFR inhibitors and/or VEGF inhibitor
proteomic profiles
blood samples analysis
Interventions
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proteomic profiles
blood samples analysis
proteomic profiles
blood samples analysis
Eligibility Criteria
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Inclusion Criteria
* 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
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Barbara Murphy, MD
Professor of Medicine, Medical Oncologist
Principal Investigators
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Barbara Murphy, MD
Role: STUDY_CHAIR
Vanderbilt-Ingram Cancer Center
Locations
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Vanderbilt-Ingram Cancer Center - Cool Springs
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center at Franklin
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
Countries
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Other Identifiers
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VU-VICC-HN-0744
Identifier Type: -
Identifier Source: secondary_id
VU-VICC-070359
Identifier Type: -
Identifier Source: secondary_id
VICC HN 0744
Identifier Type: -
Identifier Source: org_study_id
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