Study of Panitumumab Efficacy in Patients With Recurrent and/or Metastatic Head and Neck Cancer
Condition: Recurrent and/or Metastatic Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms; Recurrence
Intervention: ARM 2; ARM 1
Intervention description: Subjects will receive Cisplatin plus 5FU; Subjects will receive Panitumumab plus cisplatin and 5FU
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 658.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous Cell Carcinoma; Epidermal Growth Factor; Epidermal Growth Factor Receptor; SCCHN; Metastatic Head and Neck Cancer; EGFr; Head and Neck Cancer; Recurrent Head and Neck Cancer

Summary:

      The purpose of this study is to determine the treatment effect of Panitumumab in combination
      with chemotherapy versus chemotherapy alone as first line therapy for metastatic and/or
      recurrent squamous cell carcinoma of the head and neck.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Man or woman at least 18 years old.

          -  Histologically or cytologically confirmed metastatic and/or recurrent squamous cell
             carcinoma (or its variants) of the head and neck.

          -  Diagnosis of metastatic disease and/or recurrent disease following locoregional
             therapy and determined to be incurable by surgery or radiotherapy.

          -  Subjects who have received radiation as primary therapy are eligible if locoregional
             recurrence is in the field of radiation and has occurred ≥6 months after the
             completion of radiation therapy. Subjects whose locoregional recurrence is solely
             outside the field of radiation are eligible if the recurrence has occurred ≥ 3 months
             after the completion of radiation therapy.

          -  Measurable and non-measurable disease.

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

        Exclusion Criteria:

          -  History or known presence of Central Nervous System (CNS) metastases.

          -  History of another primary cancer, except: curatively treated in situ cervical cancer,
             or curatively resected non-melanoma skin cancer, or other primary solid tumor
             curatively treated with no known active disease present and no treatment administered
             for ≥ 2 years before randomization.

          -  Nasopharyngeal carcinoma.

          -  Prior systemic treatment for metastatic and/or recurrent SCCHN

          -  Prior cisplatin containing induction chemotherapy followed by cisplatin containing
             chemoradiotherapy

          -  Prior anti-EGFr (Epidermal growth factor receptor) antibody therapy or treatment with
             small molecule EGFr inhibitors

          -  Clinically significant cardiovascular disease (including myocardial infarction,
             unstable angina, symptomatic congestive heart failure, serious uncontrolled cardiac
             arrhythmia) less than or equal to 1 year prior to randomization. History of
             interstitial lung disease (eg, pneumonitis or pulmonary fibrosis) or evidence of
             interstitial lung disease on baseline chest computerized tomography (CT) scan.

          -  Symptomatic peripheral neuropathy grade ≥ 2 based on the CTCAE v3.0

          -  Grade ≥ 3 hearing loss based on the Common Terminology Criteria for Adverse Events
             (CTCAE) v3.0 Auditory/Ear (Hearing [without monitoring program])