Erlotinib in Treating Patients With Metastatic and/or Recurrent Head and Neck Cancer
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.
|Study Design:||Allocation: Non-Randomized
Primary Purpose: Treatment
|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)|
- Relationship between response rate and number of CA repeats in intron 1 of the EGFR
- Time to disease progression
- Compare the degree of p27 upregulation and EGFR phosphorylation in skin biopsy samples
- Relationship between erlotinib hydrochloride exposure and outcome, toxicity, and pharmacodynamic effects
|Study Start Date:||July 2005|
|Study Completion Date:||March 2007|
|Primary Completion Date:||October 2006 (Final data collection date for primary outcome measure)|
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00281866
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|Hospital Universitario 12 de Octubre|
|Madrid, Spain, 28041|
|Study Chair:||Michael K. Gibson, MD||Sidney Kimmel Comprehensive Cancer Center|