A Phase I Study of Adjuvant OSI-774 (Tarceva®) in Patients Following Combined Chemo-Radiotherapy for Locally Advanced Squamous Cell Carcinoma of the Head and Neck
- 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
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.
Masking: Open Label, Primary Purpose: Treatment
Toxicity/feasibility assessed by NCI CTC v2.0 at the end of course 1
Denis Soulieres, MD, MSC
CHUM - Hotel Dieu Hospital
United States: Federal Government