A Phase 3 Randomized Trial of Chemotherapy With or Without Panitumumab in Patients With Metastatic and/or Recurrent Squamous Cell Carcinoma of the Head and Neck (SCCHN)
- Man or woman at least 18 years old.
- Histologically or cytologically confirmed metastatic and/or recurrent squamous cell
carcinoma (or its variants) of the head and neck.
- Diagnosis of metastatic disease and/or recurrent disease following locoregional
therapy and determined to be incurable by surgery or radiotherapy.
- Subjects who have received radiation as primary therapy are eligible if locoregional
recurrence is in the field of radiation and has occurred ≥6 months after the
completion of radiation therapy. Subjects whose locoregional recurrence is solely
outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months
after the completion of radiation therapy.
- Measurable and non-measurable disease.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- History or known presence of Central Nervous System (CNS) metastases.
- History of another primary cancer, except: curatively treated in situ cervical
cancer, or curatively resected non-melanoma skin cancer, or other primary solid tumor
curatively treated with no known active disease present and no treatment administered
for ≥ 2 years before randomization.
- Nasopharyngeal carcinoma.
- Prior systemic treatment for metastatic and/or recurrent SCCHN
- Prior cisplatin containing induction chemotherapy followed by cisplatin containing
- Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with
small molecule EGFr inhibitors
- Clinically significant cardiovascular disease (including myocardial infarction,
unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
arrhythmia) less than or equal to 1 year prior to randomization. History of
interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of
interstitial lung disease on baseline chest computerized tomography (CT) scan.
- Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0
- Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events
(CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])