prism (panitumumab regimen in second-line monotherapy of head and neck cancer)

Conditions: Cancer; Carcinoma; Head and Neck Cancer; Metastases; Metastatic Cancer; Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck; Oncology; Squamous Cell Carcinoma; Tumors

Summary: to estimate the effect of second-line panitumumab monotherapy on objective response in patients with metastatic or recurrent squamous cell carcinoma of head and neck (scchn).


Eligibility criteria:
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.