Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth.

      PURPOSE: This phase II trial is studying how well erlotinib works in treating patients with
      recurrent and/or metastatic head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine the relationship between response rate and number of CA repeats in intron 1 of
           the epidermal growth factor receptor (EGFR) in patients with metastatic and/or locally
           recurrent squamous cell carcinoma of the head and neck (SCCHN) treated with the EGFR
           inhibitor erlotinib hydrochloride.

      Secondary

        -  Determine the relationship between the number of CA repeats in intron 1 of the EGFR gene
           and time to disease progression and survival in patients treated with this drug.

        -  Determine cutaneous and other toxicities of erlotinib hydrochloride in patients with
           different numbers of CA repeats in intron 1 of the EGFR gene.

        -  Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
           in patients with different numbers of CA repeats in intron 1 of the EGFR genes treated
           with this drug.

        -  Determine the relationship between erlotinib hydrochloride exposure (utilizing total and
           unbound erlotinib hydrochloride concentrations) and outcome, toxicity, and
           pharmacodynamic effects (upregulation of p27) in patients with different numbers of CA
           repeats.

      OUTLINE: This is a multicenter study. Patients are stratified according to genotype of intron
      1 of the epidermal growth factor receptor (16/16 vs 16/20 or 20/20).

      Patients receive oral erlotinib hydrochloride once daily on days 1-28. Courses repeat every
      28 days in the absence of disease progression or unacceptable toxicity.

      After completion of study treatment, patients are followed periodically.

      PROJECTED ACCRUAL: A total of 37 patients will be accrued for this study.
    

Intervention name(s): erlotinib hydrochloride
Intervention type(s): Drug
Intervention MeSH terms: Erlotinib Hydrochloride
Allocation: Non-Randomized
Primary purpose: Treatment
Keywords: 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; recurrent squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent metastatic squamous neck cancer with occult primary; metastatic squamous neck cancer with occult primary squamous cell carcinoma