A Study of Dasatinib, Cetuximab and Radiation With or Without Cisplatin in HNSCC

Exclusion Criteria

• •1. Any prior radiation above the clavicles
• •2. Prior head and neck cancer. Any other prior invasive malignancy if disease free interval is ≤ 3 years. Nonmelanomatous carcinomas of the skin and in situ cervical dysplasia are allowed if completely resected within three year interval or can be completely resected prior to starting treatment.
• •3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to cetuximab, dasatinib or other agents used in study.
• •4. Gastrointestinal tract disease resulting in an inability to take or absorb oral or enteral medication.
• •5. Concurrent medical condition which may increase the risk of toxicity, including:
• •* Pleural or pericardial effusion of any grade.
• •* Cardiac Symptoms; any of the following should be considered for exclusion:
• •* Uncontrolled angina, congestive heart failure or MI within (6 months).
• •* Diagnosed congenital long QT syndrome.
• •* Any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, or Torsades de pointes).
• •* Prolonged QTc interval on pre-entry electrocardiogram (\> 450 msec).
• •6. Subjects with hypokalemia or hypomagnesemia if it cannot be corrected prior to protocol treatment.
• •7. History of significant bleeding disorder unrelated to cancer, including:
• •* Diagnosed congenital bleeding disorders (e.g., von Willebrand's disease).
• •* Diagnosed acquired bleeding disorder within one year (e.g., acquired anti-factor VIII antibodies).
• •* Ongoing or recent (≤ 3 months) significant gastrointestinal bleeding.
• •8. Concomitant Medications, any of the following should be considered for exclusion:
• •1. Category I drugs that are generally accepted to have a risk of causing Torsades de Pointes including: (Patients must discontinue drug 7 days prior to starting dasatinib) quinidine, procainamide, disopyramide amiodarone, sotalol, ibutilide, dofetilide erythromycin, clarithromycin chlorpromazine, haloperidol, mesoridazine, thioridazine, pimozide cisapride, bepridil, droperidol, methadone, arsenic, chloroquine, domperidone, halofantrine, levomethadyl, pentamidine, sparfloxacin, lidoflazine.
• •2. The concomitant use of H2 blockers or proton pump inhibitors with dasatinib is not recommended. The use of antacids should be considered in place of H2 blockers or proton pump inhibitors in patients receiving dasatinib therapy. If antacid therapy is needed, the antacid dose should be administered at least 2 hours prior to or 2 hours after the dose of dasatinib.
• •9. Patient may not be receiving any prohibited CYP3A4 inhibitors. Refer to section 10 for other concomitant medications you may wish to prohibit based on disease/patient population.
• •10. Women who:
• •* are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period and for at least 4 weeks after cessation of study drug, or
• •* have a positive pregnancy test at baseline, or
• •* are pregnant or breastfeeding
• •11. Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious) illness.