A Phase I Study of Induction Chemotherapy with Afatinib, Ribavirin, and Carboplatin/Paclitaxel in Patients with Stage IV HPV-Associated Oropharynx Cancer

Protocol
12-150
Full Title
Phase I Study of Induction Chemotherapy with Afatinib, Ribavirin, and Weekly Carboplatin/Paclitaxel for Stage IVA/IVB HPV Associated Oropharynx Squamous Cell Cancer (OPSCC)
Phase
I
Purpose

Induction chemotherapy for advanced oropharynx cancer refers to chemotherapy that is given prior to radiation therapy. Some induction chemotherapy regimens can be associated with severe side effects. Researchers are therefore seeking different treatments that are effective while causing fewer side effects.

In this study, investigators are assessing the safety of four drugs used together in a new induction chemotherapy regimen for patients newly diagnosed with stage IV HPV-related oropharynx cancer. One drug, called afatinib, is investigational and works by inhibiting two proteins involved in cancer growth: EGFR and HER2. In this study, researchers want to find the highest dose of afatinib that can be given safely with the other drugs. It is taken orally (by mouth).

A second drug, called ribavirin, is approved for treating hepatitis C, but its use in oropharynx cancer is considered investigational. It inhibits a protein called eIF4E, which is produced in high levels in most cases of HPV-related oropharynx cancer. The dose of ribavirin used in this study is the standard dose used to treat people with hepatitis C. It, too, is taken orally.

The remaining two drugs, carboplatin and paclitaxel, are routinely used in the treatment of several forms of cancer. They will be given at a low dose, by vein (intravenously). After approximately 9 weeks of induction therapy, patients will receive the standard treatment for HPV-related oropharynx cancer (radiation therapy and low-dose chemotherapy for six and a half weeks).

Eligibility

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

  • Patients must have newly diagnosed stage IV oropharynx cancer related to HPV.
  • Patients may not have had prior chemotherapy or radiation therapy for oropharynx cancer, nor prior use of ribavirin.
  • Patients must be able to swallow pills.
  • This study is open to patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Matthew G. Fury at 646-888-4233.

Disease(s)
Head & Neck Cancer
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