A Phase I and Phase II Study of OSI-774 in Combination With Docetaxel in Squamous Cell Carcinoma of the Head and Neck
I. Determine the maximum tolerated dose and dose-limiting toxicity of erlotinib when
administered in combination with docetaxel in patients with locally advanced, metastatic, or
recurrent squamous cell carcinoma of the head and neck.
II. Determine the response rate, duration of response, time to progression, and survival of
patients treated with this regimen.
III. Determine the pharmacokinetics of this regimen in these patients. IV. Correlate the
presence of PTEN, RB, P-Akt, p15, p16, cyclin D1, p27, and p53 genes in tumor tissue with
response in patients treated with this regimen.
OUTLINE: This is a phase I, dose-escalation study of erlotinib followed by a phase II study.
PHASE I: Patients receive oral erlotinib once daily on days 1-28 and docetaxel IV over 1
hour on days 8, 15, and 22. Treatment repeats every 28 days for a total of 6 courses in the
absence of disease progression or unacceptable toxicity.
Patients receive escalating doses of erlotinib until the maximum tolerated dose (MTD) is
determined. The MTD is defined as the dose at which 2 of 3 or 2 of 6 patients experience
dose-limiting toxicity. Once the MTD is determined, an additional cohort of 6 patients
receives erlotinib at the MTD.
PHASE II: Patients receive erlotinib at the MTD and docetaxel as in phase I.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum tolerated dose of erlotinib and docetaxel, based on incidence of DLT graded according to NCI CTC version 2.0 (Phase I)
Up to 28 days
Ohio State University
United States: Food and Drug Administration
|Ohio State University Medical Center||Columbus, Ohio 43210|