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

Completed · Early Phase 1

Conditions studied: Head and Neck Cancer

In brief

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 facts

Study ID

NCT00601913

Run by

Wake Forest University Health Sciences

People needed

24

Starts

2008-03-01

Expected to finish

2014-10-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older, up to 120. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ECOG performance status 0-2
• ANC > 1,500/µL
• Platelet count > 100,000/µL
• Total bilirubin < 1.5 mg/dL
• AST/ALT < 2 times upper limit of normal
• Creatinine < 1.5 mg/dL
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

You may not qualify if…

• Uncontrolled intercurrent illness including, but not limited to, any of the following:
• Ongoing or active infection or psychiatric illness/social situations that would limit compliance with study requirements
• Significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, or myocardial infarction within the past 3 months)
• Uncontrolled congestive heart failure
• Cardiomyopathy with decreased ejection fraction
• History of interstitial lung disease (e.g., pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on chest CT scan
• Clinically significant ophthalmologic abnormalities
• HIV positivity
• PRIOR CONCURRENT THERAPY:
• More than 1 year since prior chemotherapy, biologic therapy, or hormonal therapy
• No prior radiotherapy or chemotherapy for this tumor
• No prior EGFR inhibitors
• No concurrent grapefruit or grapefruit juice
• No other concurrent investigational agents

Where it is running

• Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.