Phase 2, Single-Arm, Open-Label, Multi-Center Trial of Second-Line Panitumumab Monotherapy in Patients With Metastatic or Recurrent Squamous Cell Carcinoma of the Head and Neck

20062088

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).

2007-10-30

2010-12-15

2017-11-29

Completed

Early phase I

52

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.

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2022-10-05