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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Comprehensive Cancer Center of Wake Forest University; Wake Forest University Health Sciences
• Collaborator: National Cancer Institute (NCI)
• Treatments: Erlotinib Hydrochloride

Criteria

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx, or larynx

• SCC of the base of the tongue, pharynx, larynx, or hypopharynx are eligible provided additional biopsy tissue has been already saved in the Tumor Tissue Core Laboratory for research purposes

• SCC of the oral cavity or tonsils are eligible only if they already have or agree to have additional biopsies of tumor with adjacent normal tissue available for molecular studies

• Candidate for surgical treatment with an established date for surgery with ≥ a 15 day window of opportunity

• Measurable disease by CT scan or MRI

• No nasopharyngeal carcinoma

PATIENT CHARACTERISTICS:

Inclusion criteria:

• 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

Exclusion criteria:

• 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