Tongue Cancer Clinical Trial
Official title:
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
This phase I trial is studying the side effects and best dose of sunitinib when given together with cetuximab and radiation therapy in treating patients with locally advanced or recurrent squamous cell carcinoma of the head and neck. Sunitinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving sunitinib together with cetuximab and radiation therapy may kill more tumor cells.
PRIMARY OBJECTIVES:
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.
SECONDARY OBJECTIVES:
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
years.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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