Erlotinib and Surgery in Treating Patients With Head and Neck Cancer That Can Be Removed by Surgery

Part of paid clinical trials in Winston-Salem, North Carolina.

Sponsor
Wake Forest University Health Sciences
Study ID
NCT00601913
Phase
EARLY_PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • erlotinib hydrochloride — DRUG
  • protein analysis — GENETIC
  • western blotting — GENETIC
  • immunohistochemistry staining method — OTHER
  • laboratory biomarker analysis — OTHER
  • liquid chromatography — OTHER
  • mass spectrometry — OTHER
  • neoadjuvant therapy — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE

Study Details

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.

Key Dates

First listed
Jan 28, 2008
Start date
Mar 31, 2008
Status verified
Jul 2018
Primary completion
Oct 31, 2014
Completion
Oct 31, 2014

Study Design

Enrollment
24 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    Erlotinib

Primary Outcome Measure

Identify tissue biomarkers of EGFR activation and inhibition for which initial values and changes after treatment with erlotinib hydrochloride would best correlate with the objective response of the tumor measured clinically and radiologically

Locations (1)

FacilityCityStateZIPSite coordinators
Wake Forest University Comprehensive Cancer CenterWinston-SalemNorth Carolina27157-1096-

Find similar trials in Winston-Salem, NC

By condition
Head and neck cancer
By specialty
OncologyENT
By research site
Wake Forest University Comprehensive Cancer Center· Winston-Salem, NC

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