Head and Neck Cancer Clinical Trial
Official title:
Genotypic-Based Pharmacodynamic Evaluation of Erlotinib (Erlotinib (Tarceva™, OSI Pharmaceuticals, Uniondale, NY) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN)
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.
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.
;
Allocation: Non-Randomized, Primary Purpose: Treatment
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