Study of IMC-A12, Alone or in Combination With Cetuximab, in Participants With Recurrent or Metastatic Squamous Cell Carcinoma (MSCC) of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: IMC-A12 (cixutumumab); cetuximab (Erbitux ®)
Intervention description: IMC-A12 10 milligrams per kilogram (mg/kg) over one hour every two weeks. A cycle is defined as four weeks of therapy. Participants will continue on study until evidence of progressive disease, or unacceptable toxicity develops.; IMC-A12 10 mg/kg over one hour followed by cetuximab 500 milligrams per square meter (mg/m^2) over two hours. This sequence will be repeated every two weeks. Participants will continue on study until evidence of progressive disease or unacceptable toxicity develops.
Intervention MeSH terms: Cetuximab; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 97.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Squamous Cell Carcinoma in Head and Neck; Prior Platinum-based chemotherapy; Cetuximab; Erbitux; IMC-A12

Summary:

      The purpose of this study is to determine if IMC-A12 alone or in combination with Cetuximab
      (Erbitux®) can increase the time prior to disease progression in participants with Squamous
      Cell Head and Neck Cancer who have had disease progression and platinum-containing
      chemotherapeutic regimen.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically-confirmed squamous cell carcinoma of the oropharynx,
             hypopharynx, larynx, or oral cavity, metastasis or recurrence documented by clinical
             imaging studies

          -  Measurable disease, lesion size ≥ 2 centimeters (cm) on conventional measurement
             techniques or ≥ 1 cm on spiral computed tomography (CT) scan

          -  Clinical documentation of disease progression during treatment with or within 90 days
             after receiving the last cycle of platinum-based chemotherapy (with or without
             radiation therapy)

          -  If prior treatment with anti-epidermal growth factor receptor (EGFR) therapy, the time
             to recurrence from last exposure to anti-EGFR therapy is > 90 days

          -  Adequate hematologic function

          -  Adequate hepatic function

          -  Adequate coagulation function or is on a stable dose of an anticoagulant.

          -  Adequate renal function

          -  Fasting serum glucose <120 milligrams per deciliter (mg/dL) or below the upper limit
             of normal (ULN)

          -  Women of childbearing potential and men must agree to use adequate contraception
             (hormonal or barrier method of birth control; abstinence) prior to study entry and for
             the duration of study participation

        Exclusion Criteria:

          -  Not recovered from adverse events due to agents administered more than 4 weeks
             earlier. Neurotoxicity, must have recovered to grade ≤ 2

          -  Is receiving any other investigational agent(s)

          -  History of treatment with other agents targeting the insulin-like growth factor
             receptor (IGFR)

          -  Is receiving concurrent treatment with other anticancer therapy, including
             chemotherapy, immunotherapy, hormonal therapy, radiotherapy, chemoembolization, or
             targeted therapy

          -  History of allergic reactions attributed to compounds of chemical or biologic
             composition similar to those of cetuximab or IMC-A12

          -  Has poorly controlled diabetes mellitus. Participants with a history of diabetes
             mellitus are allowed to participate, provided that their blood glucose is within
             normal range (fasting < 120 mg/dL or below ULN) and that they are on a stable dietary
             or therapeutic regimen for this condition

          -  Pregnant or breastfeeding

          -  Is receiving therapy with immunosuppressive agents