A Phase I Trial of Concurrent Chemoradiation/Chemoreirradiation With Cetuximab (ERBITUX®), Sunitinib, and Accelerated Radiation in Patients With Locally Advanced/High-risk/Recurrent Poor Prognosis Head and Neck Cancer
I. To assess the safety, the maximum tolerated dose, and the dose limiting toxicity of
sunitinib malate when administered in combination with cetuximab and radiotherapy in
patients with locally advanced, recurrent, or second primary poor prognosis, high-risk
squamous cell carcinoma of the head and neck.
I. To describe the toxicity profile of this regimen. II. To explore the tolerability and
feasibility of sunitinib malate when administered in combination with cetuximab and
radiotherapy in these patients.
III. To assess the best overall response rate (complete and partial response) after
completion of treatment.
IV. To assess the locoregional control rate. V. To assess the distant control rate. VI. To
assess the pharmacokinetics of sunitinib malate delivered by percutaneous gastrostomy tube.
OUTLINE: This is a dose-escalation study of sunitinib malate.
Patients receive sunitinib malate orally or by percutaneous gastrostomy tube once daily,
cetuximab IV over 60-120 minutes once weekly, and undergo concurrent radiotherapy once or
twice daily, 5 days a week, for 7-9 weeks in the absence of disease progression or
unacceptable toxicity. Patients with persistent disease undergo surgical resection.
*NOTE: *Patients may have resection prior to enrollment on protocol provided they have
high-risk features for recurrence.
Some patients undergo blood sample collection at baseline and periodically during study for
pharmacokinetic analysis of sunitinib malate and metabolites.
After completion of study treatment, patients are followed up periodically for up to 6
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum-tolerated dose (MTD) of sunitinib malate
MTD is defined as the dose level immediately below the non-tolerated dose. The study will utilize a standard "3+3" design to determine the MTD. Dose limiting toxicities (DLTs) used for determining escalation of dose will be those occurring within the period of radiotherapy. Toxicity will be summarized by type and severity using the National Cancer Institute (NCI) Common Terminology Criteria.
Up to 7-9 weeks
University of Chicago Comprehensive Cancer Center
United States: Food and Drug Administration
|Loyola University Medical Center||Maywood, Illinois 60153|
|Ingalls Memorial Hospital||Harvey, Illinois 60426|
|Central Illinois Hematology Oncology Center||Springfield, Illinois 62701|
|Decatur Memorial Hospital||Decatur, Illinois 62526|
|University of Chicago Comprehensive Cancer Center||Chicago, Illinois 60637-1470|
|Froedtert and the Medical College of Wisconsin||Milwaukee, Wisconsin 53226|
|Evanston CCOP-NorthShore University HealthSystem||Evanston, Illinois 60201|
|Illinois CancerCare-Peoria||Peoria, Illinois 61615|
|Fort Wayne Medical Oncology and Hematology Inc - State Boulevard||Fort Wayne, Indiana 46845|
|Saint John's Mercy Medical Center||Saint Louis, Missouri 63141|
|University of Maryland Greenebaum Cancer Center||Baltimore, Maryland 21201|
|University of Michigan University Hospital||Ann Arbor, Michigan 48109|