A Phase 2, Randomized Trial of Chemoradiation With or Without Panitumumab in Subjects With Unresected, Locally Advanced Squamous Cell Carcinoma of the Head and Neck
Inclusion Criteria:
- Confirmed diagnosis of Stage III or IVa-b (M0) squamous cell carcinoma of the oral
cavity, oropharynx, hypopharynx or larynx
- ECOG performance status of 0 or 1 (you must be well enough to receive chemoradiation
therapy)
- You must be at least 18 years of age
- Your test results must show that your kidneys, liver and blood cells are working
adequately and that, if you are female, you are not pregnant
- You must have measurable disease
Exclusion Criteria:
- Cancer of the nasopharynx, sinus, salivary gland or skin
- History of another cancer (other than head and neck) unless treated with curative
intent and with no evidence of disease for more than 3 years, with the exception of
non-melanoma skin cancer or in situ cervical cancer
- Previous treatment with anti-EGFr antibody therapy or EGFr inhibitors
- Previous treatment for head and neck cancer, with chemotherapy, surgery (except nodal
sampling or biopsy) or radiotherapy
- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) within one year before you join the study
- Chronic obstructive pulmonary disease (pneumonia or respiratory decompensation)
resulting in hospitalization within 6 months of study screening
- History or evidence of interstitial lung disease (e.g. pneumonitis or pulmonary
fibrosis)
- Major surgery within 28 days of screening