TRYHARD: Radiation Therapy Plus Cisplatin With or Without Lapatinib in Treating Patients With Head and Neck Cancer.

Inclusion Criteria

• •Patients must have histologically or cytologically confirmed diagnosis (from primary lesion and/or lymph nodes) of Squamous Cell Cancer of the oropharynx, hypopharynx or larynx (For patients with oropharynx primary, the tumor must be negative for p16 by immunohistochemistry).
• •Patients with selected Stage III or IV disease (T2 N2-3 M0, T3-4 any N M0, T1 N2b, N2c or N3 p16 negative oropharynx cancer or T1-2 any N+ hypopharynx cancer) including no distant metastases.
• •History/Physical examination by a Radiation Oncologist and Medical oncologist prior to entering the study.
• •Examination by an ears, nose, throat (ENT) or Head \& Neck Surgeon including laryngopharyngoscopy prior to entering the study.
• •Patients must have a chest CT scan, or positron emission tomography (PET)/CT scan to rule out metastatic disease
• •Patients must have a contrast enhanced CT scan or MRI or PET/CT scan of the tumor site and neck nodes prior to entering the study.
• •Patients must have an EKG and echocardiogram (ECHO) or multigated acquisition (MUGA) scan prior to entering the study.
• •Patients must have Zubrod Performance Status of 0-1.
• •Patients must be ≥ 18 years of age.
• •Patients must have normal organ and marrow function as defined below:
• •* Absolute neutrophil count (ANC) ≥ 1,500 cells/mm3
• •* Platelets ≥ 100,000 cells/mm3
• •* Hemoglobin ≥ 8.0 g/dl
• •* Serum creatinine \< 1.5 mg/dl or creatinine clearance (CC) ≥ 50 ml/min
• •* Total bilirubin \< 2 x the institutional upper limit of normal
• •* Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x the institutional upper limit of normal
• •Patient must have magnesium, calcium, glucose, potassium and sodium levels within normal limits
• •Women of childbearing potential must have a negative pregnancy test prior to registration.
• •Patients of reproductive potential must practice effective contraception while on study and for at least 60 calendar days following treatment.
• •All patients must sign an informed consent prior to enrollment.
• •Patients must comply with the treatment plan and follow-up schedule.