Adjuvant Erlotinib After Completing Chemoradiotherapy in Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for
      their growth. Giving erlotinib after chemoradiotherapy may kill more tumor cells.

      PURPOSE: This phase I trial is studying the side effects and best dose of adjuvant erlotinib
      when given after completing chemoradiotherapy in treating patients with locally advanced
      squamous cell carcinoma (cancer) of the head and neck.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the recommended dose of adjuvant erlotinib after the completion of
           chemoradiotherapy in patients with stage III, IVA, or IVB squamous cell carcinoma of the
           head and neck.

        -  Determine the toxicity of this drug in these patients.

        -  Determine the effects of this drug on plasma and urinary angiogenic factors
           (specifically vascular endothelial growth factor receptor [VEGFR], VEGFR1, VEGFR2, and
           basic fibroblast growth factor levels) in these patients.

        -  Compare the disease-free survival of patients treated with this drug after
           chemoradiotherapy vs historical control patients treated with chemoradiotherapy alone.

        -  Correlate levels of angiogenic factors with initial blood vessel concentration in the
           tumor and the presence or absence of EGFRvIII mutation in patients treated with this
           drug.

      OUTLINE: This is an open-label, dose-escalation, multicenter study.

      Patients receive oral erlotinib once daily on days 1-28. Treatment repeats every 28 days for
      up to 6 courses in the absence of disease progression or unacceptable toxicity.

      Cohorts of 6 patients receive escalating doses of erlotinib until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients
      experience dose-limiting toxicity. Once the MTD is determined, an additional 8 patients are
      treated at that dose level.

      Patients are followed at 4 weeks, every 12 weeks for 3 years, and then annually thereafter.

      PROJECTED ACCRUAL: A total of 6-20 patients will be accrued for this study.
    

Intervention name(s): erlotinib hydrochloride; adjuvant therapy
Intervention type(s): Drug; Procedure
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the nasopharynx; stage III squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; salivary gland squamous cell carcinoma; stage III salivary gland cancer; stage IV salivary gland cancer