ERBITUX® Followed by Adjuvant Treatment With Chemoradiation and ERBITUX® for Locally Advanced Head and Neck Squamous Cell Carcinoma
Condition: Squamous Cell Carcinoma of the Head and Neck
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Intervention: Cetuximab; Surgery; Post-surgical radiation; Cisplatin or carboplatin
Intervention description: Pre-Surgery: IV, 400 mg/m2 day 1 then 250 mg/m2 alone days 8 and 15; Post-surgery: IV, 250 mg/m2 weekly concurrent with RT; Surgery for tumor; Radiation (2 Gy/d) to min of 60 Gy + max of 66 Gy post-surgery; Cisplatin 30 mg/m2 or carboplatin AUC 1.5-2/week weekly, Concurrent with radiotherapy
Intervention MeSH terms: Carboplatin; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 40.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Carcinoma; Head and Neck; Cetuximab; Locally Advanced Head and Neck Squamous Cell Carcinoma

Summary:

      There are currently no useful tests to identify patients who will respond to cetuximab
      therapy, notably because EGFR levels do not correlate with the clinical responses observed.
      Thus, the investigators are investigating the role of cellular immunity and immune escape
      mechanisms to explain the differential clinical response to cetuximab.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed, previously untreated HNC. Clinical stage
             III or IVA disease without distant metastases as determined by CT, and as defined by
             the American Joint Committee on Cancer Staging System, Sixth edition (See Appendix I).

          -  Primary tumors of the oral cavity, oropharynx, hypopharynx, or larynx will be
             included. Primary tumors of the sinuses, paranasal sinuses, or nasopharynx, or unknown
             primary tumors are NOT allowed.

          -  Macroscopic complete resection of the primary tumor must be planned.

          -  Age greater than or equal to 18 years.

          -  ECOG performance status 0-1.

          -  Adequate hematologic, renal and hepatic function, as defined by:

               -  Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, platelets
                  greater than or equal to 100,000/ul.

               -  Creatinine clearance > 40

               -  Bilirubin less than or equal to 1.5 x ULN, AST or ALT less than or equal to 2.5 x
                  ULN.

          -  Have signed written informed consent.

        Exclusion Criteria:

          -  Subjects who fail to meet the above criteria.

          -  Prior severe infusion reaction to a monoclonal antibody.

          -  Pregnancy or breastfeeding. Women of childbearing potential (WOCBP) must practice
             acceptable methods of birth control to prevent pregnancy. Prior to study enrollment,
             WOCBP must be advised of the importance of avoiding pregnancy during trial
             participation and the potential risk factors for an unintentional pregnancy. In
             addition, men enrolled on this study should understand the risks to any sexual partner
             of childbearing potential and should practice an effective method of birth control.

          -  All WOCBP MUST have a negative pregnancy test within 7 days prior to first receiving
             investigational product. If the pregnancy test is positive, the patient must not
             receive investigational product and must not be enrolled in the study. In addition,
             all WOCBP should be instructed to contact the Investigator immediately if they suspect
             they might be pregnant (e.g., missed or late menstrual period) at any time during
             study participation. The Investigator must immediately notify BMS in the event of a
             confirmed pregnancy in a patient participating in the study.

          -  Subjects with an ECOG performance status of 2 or worse.

          -  Evidence of distant metastasis.

          -  Any other malignancy active within 5 years except for non-melanoma skin cancer or
             carcinoma in situ of the cervix, DCIS or LCIS of the breast.

          -  Prior history of HNC.

          -  Prior therapy targeting the EGFR pathway.

          -  Any unresolved chronic toxicity greater than or equal to grade 2 from previous
             anticancer therapy (except alopecia), according to Common Terminology Criteria for
             Adverse Events v4.0 (CTCAE).

          -  Acute hepatitis, known HIV, or active uncontrolled infection.

          -  History of uncontrolled cardiac disease; i.e., uncontrolled hypertension, unstable
             angina, myocardial infarction within prior 6 months, untreated known coronary artery
             disease, uncontrolled congestive heart failure, and cardiomyopathy with decreased
             ejection fraction.

          -  Uncontrolled peptic or gastric ulcer disease, or gastrointestinal bleeding within
             prior 6 months.

          -  Active alcohol abuse or other illness that carries a likelihood of inability to comply
             with study treatment and follow-up.

          -  Treatment with a non-approved or investigational drug within 30 days prior to Day 1 of
             study treatment.