Adjuvant Cetuximab and Chemoradiotherapy Using Either Cisplatin or Docetaxel in Treating Patients With Resected Stage III or Stage IV Squamous Cell Carcinoma or Lymphoepithelioma of the Head and Neck
Condition: Head and Neck Cancer
MeSH terms: Carcinoma; Carcinoma, Squamous Cell
Intervention: cetuximab; cisplatin; docetaxel; radiation therapy
Intervention description: 400 mg/m^2 intravenously over 120 minutes on day 1 (week 1) followed by 250 mg/m^2 intravenously over 60 minutes in weeks 2 through 7.; 30 mg/m^2 intravenously infused over over 60 minutes in weeks 2 through 7.; 15 mg/m^2 intravenously infused over 30 minutes in weeks 2 through 7.; 60 Gy (2 Gy once a day, 5 times a week)
Intervention MeSH terms: Docetaxel; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 238.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage III lymphoepithelioma of the oropharynx; stage IV lymphoepithelioma of the oropharynx

Summary:

      RATIONALE: Monoclonal antibodies such as cetuximab can locate tumor cells and either kill
      them or deliver tumor-killing substances to them without harming normal cells. Drugs used in
      chemotherapy, such as cisplatin and docetaxel, work in different ways to stop tumor cells
      from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to
      damage tumor cells. Cisplatin and docetaxel may make the tumor cells more sensitive to
      radiation therapy. Combining a monoclonal antibody with chemoradiotherapy and giving them
      after surgery may kill any remaining tumor cells.

      PURPOSE: This randomized phase II trial is studying adjuvant cetuximab given together with
      chemoradiotherapy using cisplatin to see how well it works compared to adjuvant cetuximab
      given together with chemoradiotherapy using docetaxel in treating patients with resected
      stage III or stage IV squamous cell carcinoma (cancer) or lymphoepithelioma of the head and
      neck.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the head and neck meeting the
             following criteria:

               -  Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx
                  (excluding lip, nasopharynx, or sinuses)

               -  Gross total resection must be completed within 7 weeks of randomization, with
                  pathology demonstrating one or more of the following risk factors:

                    -  Histologic extracapsular nodal extension

                    -  Histologic involvement of ≥ 2 regional lymph nodes

                    -  Invasive cancer seen on microscopic evaluation of the resection margin, with
                       no evidence of gross tumor residual.

                    -  Tonsillar cancer patients who undergo transoral excision of all gross tumor
                       are eligible provided extracapsular nodal extension or involvement of ≥ 2
                       regional lymph nodes is histologically confirmed

               -  American Joint Committee on Cancer (AJCC) pathological stage III or IV

          -  No evidence of distant metastases

          -  No synchronous or concurrent head and neck primary tumors

        PATIENT CHARACTERISTICS:

        Age

          -  18 and over

        Performance status

          -  Zubrod 0-1

        Life expectancy

          -  Not specified

        Hematopoietic

          -  Absolute neutrophil count ≥ 2,000/mm^3

          -  Platelet count ≥ 100,000/mm^3

          -  Hemoglobin > 8.0 g/dL

        Hepatic

          -  Bilirubin ≤ 1.5 times upper limit of normal (ULN)

          -  Aspartate aminotransferase (AST) or alanine aminotransferase (ALT), and alkaline
             phosphatase meeting 1 of the following parameters:

               -  Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

               -  Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

               -  Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN

        Renal

          -  Creatinine ≤ 1.5 mg/dL

        Cardiovascular

          -  No unstable angina

          -  No uncontrolled hypertension

          -  No myocardial infarction within the past 6 months (unless successfully treated with
             coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)

          -  No uncontrolled arrhythmia

          -  No congestive heart failure

          -  No more than 2 heart-related hospitalizations within the past year

          -  No other active cardiac disease

        Pulmonary

          -  No more than 2 hospitalizations for chronic obstructive pulmonary disease within the
             past year

        Neurologic

          -  No pre-existing peripheral neuropathy ≥ grade 2

          -  No uncontrolled seizure disorder

          -  No active neurological disease

        Other

          -  No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
             polysorbate 80

          -  No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception during and for 3 months after study
             participation

        PRIOR CONCURRENT THERAPY:

        Biologic therapy

          -  No prior anti-epidermal growth factor receptor antibody therapy

        Chemotherapy

          -  More than 3 years since prior cytotoxic chemotherapy

        Endocrine therapy

          -  Not specified

        Radiotherapy

          -  No prior head and neck radiotherapy

        Surgery

          -  See Disease Characteristics

        Other

          -  No prior tyrosine kinase inhibitor therapy