A Phase II Study of the Epidermal Growth Factor Receptor Tyrosine Kinase Inhibitor, Erlotinib, in Combination With Docetaxel and Radiation in Locally Advanced Squamous Cell Cancer of the Head and Neck
- Determine the time to progression in patients with locally advanced squamous cell
carcinoma of the head and neck treated with erlotinib hydrochloride in combination with
docetaxel and radiotherapy.
- Determine objective response rate, locoregional control rate, duration of response,
patterns of failure, and overall survival in patients treated with this regimen.
- Determine the toxicities of this regimen in these patients.
- Determine the dose and effect of this treatment on biologic correlates in tumor tissue
and/or surrounding mucosa.
OUTLINE: This is a multicenter study.
Patients receive oral erlotinib hydrochloride once daily for up to 2 years in the absence of
disease progression or unacceptable toxicity. Beginning on week 3, patients receive
docetaxel IV over 1 hour once a week and radiotherapy (may be intensity-modulated) once
daily for 8 weeks in the absence of disease progression or unacceptable toxicity.
At 6-8 weeks after completion of chemoradiotherapy, patients with N2 or greater cervical
lymph node involvement at baseline or with residual disease may undergo surgery. Patients
with persistent disease during study therapy undergo salvage surgery 6-12 weeks after
completion of chemoradiotherapy.
Patients undergo blood sample, tissue biopsy, mucosal scraping, and saliva collection at
baseline and periodically during study. Samples are analyzed for markers of angiogenic
activity (VEGF, sVEGFR-2, sKIT, ICAM, and PDGF), pharmacokinetic studies, gene expression
profile, and human papilloma virus DNA by enzyme linked immunosorbent assay (ELISA),
immunohistochemistry, fluorescence in situ hybridization (FISH), and PCR.
After completion of study therapy, patients will be evaluated every 4-8 weeks for 1 year,
every 3 months for 1 year, every 4 months for 1 year, every 6 months for 2 years, and then
once a year thereafter.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
3 yrs after treatment
Min Yao, MD
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
United States: Federal Government
|Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center||Cleveland, Ohio 44106-5065|