A Phase I/IB Study of Lenvatinib and Cetuximab in Patients with Recurrent or Metastatic Squamous Cell Cancer of the Head and Neck Cancer or Skin

Full Title

IIT: A Phase I/Ib Study of Lenvatinib and Cetuximab in Patients with Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma and Cutaneous Squamous Cell Carcinoma

Purpose

The purpose of this study is to find the highest dose of the drug lenvatinib that can be given safely with cetuximab in patients with recurrent or metastatic squamous cell cancer of the head and neck or skin. Cetuximab is already approved for treating head and neck cancer and has also been shown to work against squamous cell carcinoma of the skin. It works by blocking a protein called EGFR that these cancers need to grow.

Lenvatinib is used to treat thyroid and kidney cancer; its use in this study is considered investigational. It works by inhibiting the growth of the blood vessels that tumors need to grow and spread. Cetuximab is given intravenously (by vein) and lenvatinib is taken orally (by mouth).

Eligibility

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

  • Patients must have recurrent or metastatic squamous cell cancer of the head and neck or skin that cannot be cured with surgery or radiation therapy.
  • At least 3 weeks must pass between the completion of prior anticancer therapy and entry into 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. Lara Dunn at 646-888-4233.

Protocol

17-635

Phase

I

Investigator

Co-Investigators