Erlotinib and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed by Surgery
NCT00601913 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 24
Last updated 2018-07-05
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 with erlotinib.
PURPOSE: This clinical trial is studying how well erlotinib works when given before surgery in treating patients with head and neck cancer that can be removed by surgery.
Conditions
Interventions
- DRUG
-
erlotinib hydrochloride
- GENETIC
-
protein analysis
- GENETIC
-
western blotting
- OTHER
-
immunohistochemistry staining method
- OTHER
-
laboratory biomarker analysis
- OTHER
-
liquid chromatography
- OTHER
-
mass spectrometry
- PROCEDURE
-
neoadjuvant therapy
- PROCEDURE
-
therapeutic conventional surgery
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Mercedes Porosnicu, MD · Wake Forest University Health Sciences
-
J. D. Browne, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 120 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2014-10-31
- Completion
- 2014-10-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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