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

If you are willing to take part in this study you will be asked to undergo some screening tests and procedures to confirm your eligibility. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if you do not take part in the research study. If you already had some of these tests and procedures recently, they may or may not have to be repeated. The tests and procedures include: a review of your medical history, physical exam, blood samples, urine sample, serum pregnancy test, electrocardiogram, echocardiogram and an assessment of your disease to find out the extent of your cancer. If these tests show that you are eligible to participate in the research study, you may begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study. We will collect an archive tumor specimen (leftover tissue from your prior surgery or biopsies) to confirm your cancer diagnosis. Additional tests on the tumor specimen may be performed as a part of future studies to gain new knowledge about head and neck cancer. You will receive Afatinib as a pill that you take by mouth for 7 weeks. During the first week, you will receive Afatinib alone. During the second through seventh weeks, you will receive Afatinib together with Radiation Therapy OR with Docetaxel and Radiation Therapy. Docetaxel is given intravenously, once a week during Week 2 through Week 7. Not everyone who participates in this research study will receive the same dose of the study drug. The dose you get will depend on the number of participants who have been enrolled in the study before you and how well they tolerated their doses. Afatinib needs to be taken on an empty stomach. Specific instructions about this will be included in the drug diary you will need to complete. If you take part in this research study, you will receive the same radiation that you would receive if you were not on the study. The radiation is typically done daily Monday through Friday for about 6-7 weeks. You will sign a separate consent form with your radiation oncologist that will outline what to expect with this treatment. You will be given a physical exam every week during your treatment. You will have a physical exam and be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. You will have blood tests every week during your treatment including chemistry and hematology tests and a pregnancy test if you are a woman capable of becoming pregnant before you receive your first infusion of docetaxel. You will also be asked to return to the clinic one week, four weeks and eight weeks after finishing your treatment. Most of these visits are part of routine visits after finishing treatment. If you stop the study early for any reason, you will also have a clinic visit. In either instance, the following exams and procedures will be performed: physical exam, blood tests, other tests including an electrocardiogram, MUGA scan or echocardiogram, CT scan and a PET/CT scan.