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Status: RecruitingPhase: Phase 1Diagnosis: Head and Neck CancerNCT ID: NCT01783587
(View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 12-267
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.
Conducting Institutions: Dana-Farber Cancer Institute, Brigham and Women's Hospital, Massachusetts General Hospital
Overall PI: Danielle Margalit,
Dana Farber Cancer Institute
Site-responsible Investigators: Annie W. Chan, MD,
Massachusetts General Hospital
Contacts: Dana-Farber Cancer Institute:
Patricia McHugh, RN, 617-632-3090,
Patricia_McHugh@dfci.harvard.eduMassachusetts General Hospital:
Cancer Trials Call Center, 877-789-6100