A Phase I/II Study of Dasatinib, Cetuximab and Radiation with or Without Cisplatin in Locally Advanced Squamous Cell Carcinoma of Head and Neck (HNSCC)
To determine the maximally tolerated dose of daily oral Dasatinib in combination with cetuximab and radiation in Cohort A. To determine the maximally tolerated dose of daily oral Dasatinib in combination with cisplatin/cetuximab/and radiation in Cohort B.To determine the side effects experienced and the tumor response rate in patients treated with these combinations.
-confirmed diagnosis of squamous cell carcinoma of the head and neck -disease stage will determine which cohort the patient will be treated in -measurable disease -no prior therapy for this cancer -good physical condition with good blood counts and organ function -disease-free of any prior invasive malignancy for at least 3 years
Patients with stage II or III head and neck cancer will be treated in cohort A. Patients with stage III or IV head and neck cancer will be treated in cohort B. During the phase I portion of the study, patients in each treatment cohort- A and B, will receive weekly cetuximab intravenously starting 2 weeks prior to the start of radiation therapy and continuing throughout the 7 week course of radiation. Dasatinib will be taken orally daily starting one week prior to radiation and continuing throughout the course of radiation. In each cohort, the dose of Dasatinib will be given to patients at one of three fixed dose levels to determine the maximally tolerated dose of Dasatinib. Patients in cohort B will also receive cisplatin intravenously every 3 weeks for a total of 3 doses. During the phase II portion of the study, treatment in cohorts A and B will continue as in the phase I portion, however the daily dose of Dasatininb will be at the fixed maximally tolerated dose determined during the phase I portion of the study.
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