Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract
Condition: Head and Neck Cancer; Precancerous Condition
MeSH terms: Precancerous Conditions
Intervention: cetuximab
Intervention description: given IV
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 35.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: hypopharyngeal cancer; laryngeal cancer; lip and oral cavity cancer; nasopharyngeal cancer; oropharyngeal cancer; paranasal sinus and nasal cavity cancer; salivary gland cancer; precancerous condition

Summary:

      RATIONALE: Monoclonal antibodies, such as cetuximab, can block abnormal cell growth in
      different ways. Some block the ability of abnormal cells to grow and spread. Others find
      abnormal cells and help kill them or carry cell-killing substances to them.

      PURPOSE: This randomized phase II trial is studying how well cetuximab works in treating
      patients with precancerous lesions of the upper aerodigestive tract.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed high-risk, premalignant lesions of the upper aerodigestive
             tract, meeting one of the following criteria:

               -  Unresectable, diffuse high-grade dysplasia, defined as moderate or severe
                  dysplasia that is not assessable by physical examination and/or that cannot be
                  excised by standard surgical techniques

               -  previously treated HNSCC with persistent or recurrent high grade dysplasia with
                  no evidence of head and neck malignancy for three months prior to enrollment or
                  who have successfully completed therapy for head and neck malignancy more than 3
                  months prior to enrollment.

               -  Dysplastic lesions with 3p or 9p loss of heterozygosity

          -  Disease location amenable to endoscopic biopsy in an outpatient clinical setting or
             operative biopsy within the routine scheduling and practice of clinical care

               -  No medical contraindication to biopsy of the target lesion

               -  Pathology must be reviewed by the Johns Hopkins Hospital Department of Pathology

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-1

          -  Absolute neutrophil count (ANC) > 1,000/mm³

          -  Platelet count > 75,000/mm³

          -  Creatinine clearance > 60 mL/min

          -  Total serum bilirubin < 1.5 mg/dL

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after
             completion of study therapy

          -  No concurrent illness likely to preclude study therapy or surgical resection

          -  Patients with a history of a curatively treated malignancy are eligible provided they
             are disease-free and have a survival prognosis that exceeds 5 years

          -  No evidence of clinically active interstitial lung disease

               -  Patients with chronic, stable radiographic changes who are asymptomatic are
                  eligible

          -  No history or radiological evidence of pulmonary fibrosis

          -  No acute myocardial infarction within the past 3 months

          -  No uncontrolled angina, arrhythmia, or congestive heart failure

          -  No evidence of other severe or uncontrolled systemic disease (e.g., unstable or
             uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  No evidence of any other significant clinical disorder or laboratory finding that
             would preclude study participation

          -  No known severe hypersensitivity to cetuximab or any of its excipients

          -  No prior hypersensitivity reaction to chimerized or murine monoclonal antibody therapy

          -  No severe abnormality of the cornea

        PRIOR CONCURRENT THERAPY:

          -  See Disease Characteristics

          -  Recovered from prior oncologic or other major surgery or biopsy

          -  More than 30 days since prior non-approved or investigational drugs

          -  No prior chemotherapy, radiotherapy, or surgery for the premalignant lesions

          -  No prior EGFR-targeted agents (e.g., cetuximab, gefitinib, or erlotinib)