Multicenter Randomized Phase II Study of Erlotinib, Cisplatin and Radiotherapy Versus Cisplatin and Radiotherapy in Patients With Stage III and IV Squamous Cell Carcinoma of the Head and Neck
I. Compare the complete response rate in patients with locally advanced head and neck
cancer, treated with cisplatin, radiotherapy and erlotinib (erlotinib hydrochloride) versus
cisplatin and radiotherapy alone.
I. Evaluate whether the addition of erlotinib increases the acute and long term toxicities
of cisplatin and radiotherapy, in patients with locally advanced head and neck cancer.
II. Compare the disease-free and overall survivals of patients with locally advanced head
and neck cancer treated with cisplatin and radiotherapy, with and without erlotinib.
III. Evaluate whether the symptomatic improvement observed in the first week of erlotinib
alone predicts for complete response and long term disease control.
IV. Correlate epidermal growth factor receptor (EGFR), p16 and excision repair
cross-complementing 1 (ERCC-1) expression with response outcome to therapy with cisplatin
and radiation with and without erlotinib.
V. Identify other molecular correlates that may be relevant in the pathogenesis of squamous
cell carcinoma of head and neck (SCCHN) or response to therapy.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cisplatin intravenously (IV) on days 1, 22, and 43 and undergo
3-dimensional conformal or intensity modulated radiotherapy once daily, 5 days per week, on
days 1-47. Patients also receive erlotinib hydrochloride orally (PO) once daily (QD) on days
-7 to 47.
ARM II: Patients receive cisplatin and undergo radiotherapy as in Arm I.
Within 10-14 weeks after completion of study treatment, patients with N2 or N3 disease at
the time of screening undergo a neck dissection.
After completion of study treatment, patients are followed up periodically for 5 years.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Comparison of the Percentage of Participants With a Complete Response in Each Treatment Arm
Complete response requires both a pathological complete response (independent of observer) and a complete response radiologically (RECIST 1.0).
12 weeks after the completion of therapy
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
United States: Institutional Review Board
|Medical University of South Carolina||Charleston, South Carolina 29425-0721|
|Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium||Seattle, Washington 98109|
|University of North Carolina||Chapel Hill, North Carolina 27599|
|Multicare Health System||Tacoma, Washington 98415|
|University of Miami Miller School of Medicine-Sylvester Cancer Center||Miami, Florida 33136|
|Alaska Oncology and Hematology LLC||Anchorage, Alaska 99508|
|University of New Mexico Health Science CCOP||Albuquerque, New Mexico 87131|
|New Hanover Radiation Oncology Center||Wilmington, North Carolina 28401|
|University of Tennessee Cancer Institute-Boston Cancer Group PLC||Memphis, Tennessee 38104|