Safety Study of Afatinib and Postoperative Radiation Therapy to Treat Head and Neck Cancer
Status:
Completed
Trial end date:
2018-06-01
Target enrollment:
Participant gender:
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.