A Phase I Study of Cabozantinib plus Cetuximab in Patients with Recurrent or Metastatic Head and Neck Cancer

Full Title

A Phase 1 Study of Concurrent Cabozantinib and Cetuximab in Recurrent or Metastatic Head and Neck Squamous Cell Cancer

Purpose

Cabozantinib is an anticancer drug used to treat advanced kidney, hepatocellular, and medullary thyroid cancer. In this study, researchers are determining the highest dose of cabozantinib that can be given safely with another medication, cetuximab, in patients with head and neck cancer that has come back or continued to grow despite curative treatment.

Cetuximab is already used to treat head and neck cancer, but some tumors become resistant to it. It is given intravenously (by vein). Cabozantinib is an oral medication (taken by mouth) that slows the growth of cancer cells by cutting off the blood supply that a tumor needs to survive and grow. Researchers think that cabozantinib will inhibit head and neck cancer growth and that adding cabozantinib to cetuximab will restore cetuximab’s ability to work in patients who have become resistant to it.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic head and neck squamous cell carcinoma that has come back or continued to grow despite prior curative treatment. Previous treatment with cabozantinib is not permitted.
  • Patients should recover from the serious side effects of prior treatments before entering the study.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and are capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Loren Michel at 848-225-6113.

Protocol

18-303

Phase

I

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators