Preoperative Treatment With Cetuximab and/or IMC-A12
Condition: Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; IMC-A12; Surgical tumor resection
Intervention description: First dose of 400 mg/m^2 by vein on Days 1 and 8 over 2 hours, second dose of 250 mg/m^2 on week 2 and 3 (if applicable) given over 1 hour.; 6 mg/kg/week by vein on Days 1 and 8 over 1 hour on weeks 1 and 2 and 3 (if applicable).; Surgical tumor resection on Day 10.
Intervention MeSH terms: Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Head and Neck Cancer; Squamous cell carcinoma of the head and neck; HNSCC; Cetuximab; IMC-A12; Tumor; Biomarkers; Phospho-AKT; Surgical resection

Summary:

      The goal of this clinical research study is to give cetuximab and/or IMC-A12 before surgery
      for squamous cell carcinoma of the head and neck, in order to learn if these study drugs may
      cause changes in biomarkers. Biomarkers are chemical "markers" in the blood and/or tissue
      that may be related to a reaction to study treatment.

      The safety of the study treatments will also be studied.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Histologically or cytologically-confirmed diagnosis of squamous cell carcinoma of the
             head and neck (excluding carcinomas of the nasopharynx types II and III according to
             the World Health Organization criteria), for whom surgical resection of the tumor is
             planned as part of the treatment. Patients with skin squamous cell carcinomas of the
             head and neck region will also be included in this study.

          2. There is availability of a baseline, paraffin-embedded, tumor specimen for biomarker
             evaluation. No anti-neoplastic treatment is allowed between the time from obtaining
             the baseline tumor specimen and randomization. If a baseline tumor specimen is not
             available, a biopsy of the tumor will be performed prior to randomization.

          3. Prior treatment with biological agents targeted to the epidermal growth factor
             receptor is allowed, provided the time from last exposure to this treatment was >/= 6
             months.

          4. The patient has a fasting serum glucose < 130 mg/dL and HbA1C < 7.0%. Patients with a
             history of diabetes mellitus are allowed to participate, provided that they are on a
             stable dietary or therapeutic regimen for this condition.

          5. The patient has adequate renal function, defined by serum creatinine </= 1.5 x the
             institutional upper limit of normal (ULN), or creatinine clearance >/=60 mL/min for
             patients with creatinine levels above the ULN.

          6. Because the teratogenicity of cetuximab and IMC-A12 is not known, 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.

          7. The patient is age >/= 18 years.

          8. The patient or the patient's legally authorized representative has the ability to
             understand and the willingness to sign a written informed consent document.

          9. ECOG performance status of 0-2.

        Exclusion Criteria:

          1. Patients receiving any other agent (investigational or not) with potential
             anti-neoplastic activity within 3 weeks prior to obtaining the baseline tumor specimen
             for biomarker evaluation.

          2. Patients receiving concomitant radiation.

          3. Prior treatment with an agent targeted at the insulin-like growth factor-1 receptor.

          4. History of allergic reactions attributed to compounds of chemical and biological
             composition similar to those of cetuximab or IMC-A12.

          5. Pregnant patients, or patients who are breast feeding (patients who have a positive
             pregnancy test within the first 30 days before the first dose of treatment are
             excluded).

          6. Patients with uncontrolled illnesses which, in the opinion of the investigator, could
             be aggravated by the administration of the study drug(s).