PURPOSE: This trial is studying if and how well lapatinib adds to the effectiveness of radiation therapy plus cisplatin in patients who have head and neck cancer that is not related to the HPV virus.
TRYHARD: A Phase II, Randomized, Double Blind, Placebo-Controlled Study of Lapatinib (Tykerb®) for Non-HPV Locally Advanced Head and Neck Cancer With Concurrent Chemoradiation
Non-HPV Locally Advanced Head and Neck CancerLapatinibCisplatin
You can join if…
Open to people ages 18 years and up
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 N3p16 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 ENT or Head & Neck Surgeon including laryngopharyngoscopy prior to entering the study.
Patients must have a chest CT scan, or 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 ECHO or 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: