Cetuximab in Treating Patients With Precancerous Lesions of the Upper Aerodigestive Tract
Condition: Head and Neck Cancer; Precancerous Condition
MeSH terms: Precancerous Conditions
Study type: Interventional
Phase: Phase 2

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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  To determine the histologic response rate in patients with high-risk, premalignant
           lesions of the upper aerodigestive tract treated with cetuximab.

      Secondary

        -  To determine the clinical response rate in these patients.

        -  To determine if patterns of epidermal growth factor receptor (EGFR) component expression
           are altered in these patients.

        -  To determine the change in status of genetic alterations, including loss of
           heterozygosity, in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified by lesion type [diffuse
      dysplasia vs recurrent dysplasia vs dysplastic lesions with 3p or 9p loss of heterozygosity
      (LOH)]. Patients are randomized to 1 of 2 arms.

        -  Arm I (treatment): Patients receive cetuximab IV over 1-2 hours on days 1, 8, 15, 22,
           29, 36, 43, and 50 in the absence of disease progression or unacceptable toxicity.

        -  Arm II (control): Patients receive regular follow-up care. Patients have the option of
           receiving cetuximab after completion of the study.

      In both arms, patients with persistent or recurrent high-grade dysplasia or dysplastic
      lesions with 3p or 9p LOH undergo surgical resection, if feasible, after week 8.

      Tumor biopsy samples are obtained at baseline* and after week 8 for histologic and biomarker
      correlative studies. Tissue samples are analyzed by histopathology to determine histologic
      changes in post-treatment lesions and by immuno-histochemistry (IHC) to measure expression
      and activation of EGFR signaling pathway components. LOH studies are also performed.

      NOTE: *Paraffin-embedded tissue from the original diagnostic biopsy may be used for baseline
      assessment, if the diagnostic biopsy was performed within 3 months prior to study entry.

      After completion of study therapy, patients are followed at approximately 1 month, every 3
      months for 2 years, and then every 6 months for up to 5 years as per routine standard of
      care.
    

Intervention name(s): cetuximab
Intervention type(s): Biological
Intervention description(s): given IV
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
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