Blood Proteins in Predicting Treatment Benefit in Patients With Recurrent and/or Metastatic Head and Neck Squamous Cell Cancer
This study has been completed.
Sponsor:
Vanderbilt-Ingram Cancer Center
Collaborator:
Information provided by (Responsible Party):
Barbara Murphy, MD, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT00896675
First received: May 9, 2009
Last updated: March 29, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Other: proteomic profiles |
| Study Type: | Observational |
| Study Design: | Observational Model: Case-Only Time Perspective: Retrospective |
| Official Title: | Proteomic Prediction of Clinical Benefit in HNSCC |
Resource links provided by NLM:
Further study details as provided by Vanderbilt-Ingram Cancer Center:
Primary Outcome Measures:
- Identification of patients who will benefit from treatment with EGFR and/or VEGF inhibitors based on serum proteomic profiles [ Time Frame: upon analysis of each patient tissue collection ] [ Designated as safety issue: No ]
| Enrollment: | 352 |
| Study Start Date: | June 2007 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| patients treated with EGFR inhibitors and/or VEGF inhibitor |
Other: proteomic profiles
blood samples analysis
|
| NOT treated with EGFR inhibitors and/or VEGF inhibitor |
Other: proteomic profiles
blood samples analysis
|
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| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Head and Neck cancer patients
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00896675
Locations
| United States, Tennessee | |
| Vanderbilt-Ingram Cancer Center - Cool Springs | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center at Franklin | |
| Nashville, Tennessee, United States, 37064 | |
| Vanderbilt-Ingram Cancer Center | |
| Nashville, Tennessee, United States, 37232-6838 | |
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
Investigators
| Study Chair: | Barbara Murphy, MD | Vanderbilt-Ingram Cancer Center |
More Information
No publications provided
| Responsible Party: | Barbara Murphy, MD, Professor of Medicine, Medical Oncologist, Vanderbilt-Ingram Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00896675 History of Changes |
| Other Study ID Numbers: | VICC HN 0744, P30CA068485, VU-VICC-HN-0744, VU-VICC-070359 |
| Study First Received: | May 9, 2009 |
| Last Updated: | March 29, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by Vanderbilt-Ingram Cancer Center:
|
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 |
Additional relevant MeSH terms:
|
Neoplasms, Squamous Cell Head and Neck Neoplasms Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms by Site |
ClinicalTrials.gov processed this record on May 23, 2013