Cetuximab and Combination Chemotherapy in Patients With Stage III-IV Resectable Oropharynx Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Intervention: cisplatin; docetaxel; fluorouracil; Cetuximab
Intervention description: 75 mg/m², day 1. 3 cycles; 75 mg/m² Day 1. 3 cycles; 750 mg/m² day 1 to day 5. 3 cycles; 400 mg/m² Day 1, 250 mg/m² Day 8 and Day 15. 3 cycles.
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No
Keywords: stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; tongue cancer

Summary:

      RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
      ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and
      help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as
      docetaxel, cisplatin, and fluorouracil, work in different ways to stop the growth of tumor
      cells, either by killing the cells or by stopping them from dividing. Giving more than one
      drug (combination chemotherapy) together with cetuximab may kill more tumor cells.

      PURPOSE: This phase II clinical trial is studying how well cetuximab given together with
      combination chemotherapy works in treating patients with stage III or stage IV oropharynx
      cancer that can be removed by surgery.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed squamous cell carcinoma of the oropharynx

               -  Stage III (T3 or T1-2, N1-2, M0) or nonmetastatic stage IV (T4 or T1-3, N3, M0)
                  disease

               -  Resectable disease

          -  Measurable or evaluable disease

          -  Tumor tissue available

        PATIENT CHARACTERISTICS:

        Inclusion criteria:

          -  WHO performance status 0-1

          -  ANC ≥ 1,500/mm3

          -  Platelet count ≥ 100,000/mm3

          -  Hemoglobin ≥ 9 g/dL

          -  Creatinine < 1.5 times upper limit of normal (ULN)

          -  Creatinine clearance ≥ 60 mL/min

          -  AST and ALT < 5 times ULN

          -  Bilirubin < 1.5 times ULN

          -  Not pregnant or nursing

          -  Fertile patients must use effective contraception

          -  Affiliated with social security (including CMU)

        Exclusion criteria:

          -  Cardiovascular accident (myocardial infarction, cerebral vascular accident) within the
             past 6 months

          -  Serious and/or uncontrolled cardiac or respiratory disease (pulmonary fibrosis,
             interstitial pneumopathy)

          -  Other cancer within the past 5 years except for resected skin cancer, localized
             cutaneous or totally resected melanoma, or resected carcinoma in situ of the cervix

          -  Auditory condition precluding the use of cisplatin

          -  Contraindication due to psychological, social, or geographical reasons that may impede
             proper monitoring of treatment

          -  Persons under guardianship or trusteeship, or prisoners of law

        PRIOR CONCURRENT THERAPY:

          -  No prior treatment, including chemotherapy or radiotherapy

          -  No concurrent phenytoin, live attenuated vaccines, or parenteral aminoglycosides