PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)

Inclusion Criteria:

* Histologically or cytologically confirmed squamous cell carcinoma of head and neck (SCCHN) of oropharynx, oral cavity, hypopharynx, or larynx with at least 1 measurable lesion using computed tomography (CT) or magnetic resonance imaging (MRI) scan
* Diagnosis of recurrent disease determined to be incurable by surgery or radiotherapy
* Karnofsky Performance Status (KPS) score ≥ 60% at screening
* Men or women age ≥18 years
* Adequate hematologic, electrolyte and hepatic functions and negative pregnancy test

Exclusion Criteria:

* Subject received \> 1 chemotherapy regimen for the treatment of metastatic or recurrent disease
* Concomitant chemotherapy for recurrent disease administered solely for the purpose of radiation sensitization during re-irradiation will not be counted towards this chemotherapy regimen
* Nasopharyngeal carcinoma, salivary gland and primary skin SCCHN, or symptomatic central nervous system (CNS) metastases
* History of interstitial lung disease, significant cardiovascular disease, or another primary cancer
* Known positive test for human immunodeficiency virus (HIV) infection, hepatitis C virus, acute or chronic hepatitis B infection
* Known allergy or hypersensitivity to any component of panitumumab
* Prior anti-epidermal growth factor receptor (EGFr) antibody therapy (eg, panitumumab, cetuximab) or treatment with small molecule EGFr inhibitors (eg, gefitinib, erlotinib, lapatinib) for recurrent or metastatic disease with the following exceptions:

  * Prior EGFr inhibitor therapy is allowed if received as part of prior multimodality treatment (eg, as radiation sensitizer) and completed \> 24 weeks prior to randomization
  * Subjects who received no more than one dose of cetuximab and discontinued prior to progression due to documented severe infusion reaction are eligible.
* Significant thromboembolic event ≤ 8 weeks prior to enrollment
* Subjects not recovered from all previous acute radiotherapy-related toxicities
* History of severe skin disorder that in the opinion of the investigator may interfere with study conduct
* History of any medical, or psychiatric condition, or laboratory abnormality that may interfere with the interpretation of study results
* Subject is currently in a clinical trial ≤ 30 days prior to enrollment
* Subjects requiring use of immunosuppressive agents however corticosteroids are allowed
* Man or woman of child-bearing potential who do not consent to use adequate contraceptive precautions during the course of the study
* Female subject who is pregnant or breast-feeding
* Subject requiring major surgery using general/spinal anesthesia ≤ 28 days prior to enrollment, or minor surgery ≤ 14 days prior to enrollment.