A Study in Head and Neck Cancer

Inclusion Criteria:

• The participant has histologically or cytologically confirmed head and neck cancer, with the exception of lymphomas involving the head and neck region. Tumors of unknown origin presenting in the head and neck region or local or recurrent skin cancers in the head and neck region are also acceptable.
• The participant has measurable or non-measurable disease.
• If the patient has received prior treatment with anti-EGFR therapy, the time to recurrence from the last cetuximab or other anti-EGFR agent exposure is > 90 days. If the patient has received therapy with an anti-EGFR tyrosine kinase inhibitor, the time to recurrence from the last exposure is > 30 days.
• The participant has a life expectancy of greater than 3 months.
• The participant has an Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2.
• The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (μL), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/μL.
• The participant has adequate hepatic function as defined by a total bilirubin less than or equal to 2 x the upper limit of normal (ULN), aspartate transaminase (AST, SGOT) and alanine transaminase (ALT, SGPT) less than or equal to 3 x the ULN (or less than or equal to 5 x the ULN in the presence of known liver metastases).
• The participant has adequate renal function as defined by serum creatinine less than or equal to 1.5 x the institutional ULN or creatinine clearance greater than or equal to 60 mL/min for participants with creatinine levels above the ULN.
• The participant has the ability to understand, and the willingness to sign, a written informed consent document.
• Prior systemic chemotherapy for head and neck cancer is allowed only if performed as part of a multimodal treatment for locally advanced disease and/or as first-line treatment for recurrent/metastatic disease. The time to recurrence from the last exposure of systemic chemotherapy must be more than 6 weeks. The first-line treatment for recurrent/metastatic disease must not have contained a platinum agent.

Exclusion Criteria:

• The participant has lymphoma involving the head or neck region.
• The participant has symptomatic brain or leptomeningeal metastasis.
• The participant has not recovered from adverse events due to agents administered more than 4 weeks earlier. Neurotoxicity, if present, must have improved to Grade less than 2 per the National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) v 3.0.
• The participant is receiving any other investigational agent(s).
• The participant is receiving concurrent treatment with other anticancer therapy, including chemotherapy, immunotherapy, hormonal therapy, RT, chemoembolization, or targeted therapy. Participants receiving palliative radiation therapy to bony metastases prior to the first dose of study medication are eligible.
• The participant is receiving therapy with immunosuppressive agents.
• The participant has known drug or alcohol abuse.
• The participant has uncontrolled hypertension defined as systolic blood pressure greater than or equal to 180 mm Hg or diastolic blood pressure greater than or equal to 130 millimeters of mercury (mm Hg).
• The participant has a history of allergic reactions attributed to compounds of chemical or biologic composition similar to those of cetuximab or carboplatin.
• The participant has a medical or psychological condition that would not permit the participant to complete the study or sign informed consent.
• The participant has clinically relevant coronary artery disease or history of myocardial infarction in the last 12 months or high risk of uncontrolled arrhythmia or uncontrolled cardiac insufficiency.
• The participant, if female, is pregnant (confirmed by serum or urine beta-human chorionic gonadotropin [β-HCG] pregnancy test) or breastfeeding
• The participant has had a known positive test result for the human immunodeficiency virus.
• The participant has an active infection (requiring intravenous [IV] antibiotics), including tuberculosis.
• The participant has a history of another active primary invasive cancer within the previous 2 years, excluding non-melanoma skin cancer.