Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer

Study Summary

This research study is a Phase I clinical trial. Phase I clinical trials test the safety of an investigational drug. Phase I studies also try to define the appropriate dose of the investigational drug to use for further studies. "Investigational" means that the drug is still being studied and that research doctors are trying to find out more about it-such as the safest dose to use and the side effects it may cause. Afatinib has been studied in other clinical trials of participants with head and neck cancer, lung cancer, and breast cancer. This dose of Afatinib has also been studied in other research studies. This is the first clinical trial to study Afatinib in combination with Radiation Therapy. The purpose of this study is to determine the safest dose of Afatinib when given in combination with Radiation Therapy or in combination with Radiation Therapy and chemotherapy for head and neck cancer. Afatinib is a drug that may stop cancer cells from growing abnormally. This drug works by blocking multiple proteins known to play a role in the growth of cancer cells. Information from laboratory research studies suggests that this drug may help to make head and neck cancer cells more sensitive to Radiation Therapy. The other therapy in this research study is Radiation Therapy or Radiation Therapy plus a chemotherapy drug called Docetaxel. After surgery, Radiation Therapy and chemotherapy is the standard treatment if you have high risk disease. "High risk disease" means that without additional therapy, there is a high risk that the disease may return. In this study, participants with high-risk disease will receive Radiation Therapy and Docetaxel and Afatinib. "Intermediate risk" means that there is an intermediate risk that the disease may return. Radiation Therapy alone is the standard treatment approach for intermediate risk cancer. In this study, participants with intermediate risk disease will receive Radiation Therapy and Afatinib.

Primary Outcome

All participants who receive any amount of study drug will be evaluable for toxicity. The primary outcome measure is the incidence of a physician-assessed dose-limiting toxicity (DLT) at a given dose-level of afatinib. Participants will be assessed for a DLT at least once per week during the course of therapy, including the one-week afatinib lead-in period and the 6-7 weeks of radiation therapy. DLT's are defined as the incidence of a severe or life-threatening toxicity (grade 3-4) as defined by

Interventions

• DRUG Docetaxel
• RADIATION Radiation Therapy
• DRUG Afatinib