PRISM (Panitumumab Regimen In Second-line Monotherapy of Head and Neck Cancer)
Condition: Cancer; Carcinoma; Head and Neck Cancer; Metastases; Metastatic Cancer; Metastatic or Recurrent Squamous Cell Carcinoma of Head and Neck; Oncology; Squamous Cell Carcinoma; Tumors
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms; Squamous Cell Carcinoma of Head and Neck
Intervention: Panitumumab
Intervention description: Panitumumab was administered over a 1 hour intraveneous (IV) infusion at a dose of 9 mg/kg every 21 days.
Intervention MeSH terms: Panitumumab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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.