Tongue Cancer Clinical Trial
Official title:
A Phase I/II Clinical Trial of Sorafenib in Combination With Cisplatin and Docetaxel in Patients With Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (SCCHN)
This phase I/II trial studies the side effects and the best dose of sorafenib tosylate and docetaxel when given together with cisplatin and to see how well they work in treating patients with recurrent or metastatic squamous cell carcinoma of the head and neck. Drugs used in chemotherapy, such as cisplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Sorafenib tosylate may also help cisplatin and docetaxel work better by making tumor cells more sensitive to the drugs. Giving sorafenib tosylate, cisplatin, and docetaxel may be an effective treatment for squamous cell carcinoma of the head and neck.
PRIMARY OBJECTIVES:
I. To define progression-free survival of patients with recurrent/metastatic squamous cell
carcinoma treated with cisplatin/docetaxel/sorafenib (sorafenib tosylate) (CDS) combination
chemotherapy. (Phase II) II. To determine the optimal doses of cisplatin/docetaxel/sorafenib
to be used in the phase II portion of the trial. (Phase I)
SECONDARY OBJECTIVES:
I. To determine overall survival, response rate, conduct biomarker studies, toxicities.
OUTLINE: This is a phase I, dose-escalation study of sorafenib tosylate and docetaxel
followed by a phase II study.
Patients receive sorafenib tosylate orally (PO) twice daily (BID) on days 1-14 of course 0.
Beginning in course 1, patients receive sorafenib tosylate PO BID on days 1-21, docetaxel
intravenously (IV) over 1 hour on day 1, and cisplatin IV over 1 hour on day 1. Treatment
repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity. Patients then receive sorafenib tosylate PO BID in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 4 weeks.
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