Patritumab With Cetuximab and a Platinum Agent for Squamous Cell Carcinoma (Cancer) of the Head and Neck (SCCHN )
Condition: Head and Neck Neoplasms
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Head and Neck Neoplasms
Intervention: Patritumab; Cetuximab; Cisplatin; Carboplatin; Placebo
Intervention description: Patritumab initial loading dose is 18 mg/kg IV over 60 minutes followed by a maintenance dose of 9 mg/kg IV over 60 minutes (± 10 minutes) every three weeks; Cetuximab 400 mg/mg/m^2 IV loading dose, followed by 250 mg/m^2 weekly; Cisplatin at 100 mg/m^2 IV infused over 1 hour, every three weeks up to a maximum of 6 cycles; Carboplatin IV over 30 to 60 minutes, every 3 weeks for a maximum of 6 cycles; Placebo to match patritumab
Intervention MeSH terms: Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 87.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous cell cancer of the head and neck; Squamous cell carcinoma; Head and neck cancer; Neoplasms by site

Summary:

      This study will test an investigational study drug called patritumab. It is a 'randomized
      study' which means participants have an equal chance of being assigned to receive the
      experimental medication (patritumab) or a substance that looks like the experimental product,
      but is not (placebo). Patritumab may work when combined with other medications that are
      approved for the treatment of head and neck cancer. They are called cetuximab, cisplatin or
      carboplatin. All participants will receive the other medications approved for treatment of
      head and neck cancer, even if they do not receive the experimental product.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Has histologically confirmed recurrent disease or metastatic SCCHN tumor and/or from
             its lymph nodal metastases originating from the oral cavity, oropharynx, hypopharynx,
             and larynx

          -  Has or be willing to provide tumor tissue for testing

          -  Has measurable disease per Response Evaluation Criteria in Solid Tumor (RECIST)
             version 1.1

          -  Has Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

          -  Has adequate hematological function per protocol

          -  Has adequate renal function per protocol

          -  Has adequate hepatic function per protocol

          -  Agrees to use effective contraception while on the study and for 6-months after the
             end of the study

          -  Provides written informed consent(s)

        Exclusion Criteria:

          -  Has left ventricular ejection fraction (LVEF) <50%

          -  Had prior epidermal growth factor receptor (EGFR) targeted regimen

          -  Had prior anti-human epidermal growth factor receptor 3 (anti-HER3) therapy

          -  Had prior chemotherapy for recurrent/metastatic disease

          -  Had anti-cancer therapy between biopsy and submission of sample

          -  Has history of other malignancies, except adequately treated non-melanoma skin cancer,
             curatively treated in-situ disease, or other solid tumors curatively treated with no
             evidence of disease for ≥ 2 years

          -  Has known history of brain metastases or active brain metastases

          -  Has uncontrolled hypertension

          -  Has clinically significant electrocardiograph (ECG) findings

          -  Had myocardial infarction within 1 year before enrollment, symptomatic congestive
             heart failure, unstable angina, or arrhythmia requiring medication

          -  Had platinum-containing drug therapy with radiotherapy less than 6 months before study
             drug treatment

          -  Had therapeutic or palliative radiation therapy or major surgery within 4 weeks before
             study drug treatment