Docetaxel, Cisplatin, and Fluorouracil Followed By Cetuximab and Radiation Therapy in Treating Patients With Locally Advanced Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: 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. 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. Radiation therapy
      uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with
      cetuximab and radiation therapy may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving docetaxel, cisplatin, and
      fluorouracil together with cetuximab and radiation therapy works in treating patients with
      locally advanced head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Evaluate the progression-free survival of patients with locally advanced squamous cell
           carcinoma of the head and neck treated with induction chemotherapy comprising docetaxel,
           cisplatin, and fluorouracil followed by concurrent cetuximab and radiotherapy.

      Secondary

        -  Assess the objective response rate in patients treated with this regimen.

        -  Assess the best overall response rate, overall survival, local-regional control, and
           distant failure in patients treated with this regimen.

        -  Assess the acute and long-term toxicity associated with this regimen in these patients.

        -  Assess quality of life and swallowing in patients treated with this regimen.

        -  Determine the accuracy of PET/CT scan in evaluating objective response; in detecting
           residual disease at primary sites and nodes; in guiding the recommendation for salvage
           surgery or for neck dissection; and in early detection of recurrent or metastatic
           disease.

      OUTLINE: Patients are stratified according to nodal status (N2b-c or N3 vs N0-2a), tumor
      characteristics of invasiveness (present vs absent), human papilloma virus (HPV) status
      (positive vs negative), and primary tumor site (hypopharynx vs larynx vs oropharynx).

      Patients receive induction chemotherapy comprising docetaxel IV over 1 hour and cisplatin IV
      over 1 hour on day 1 and fluorouracil IV continuously on days 1-4. Treatment repeats every 3
      weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.
      Beginning 3-4 weeks after completion of induction chemotherapy, patients receive cetuximab IV
      once weekly for 7 weeks. Beginning 1 week after the first dose of cetuximab, patients undergo
      concurrent intensity-modulated radiotherapy or conventional 3-dimensional radiotherapy once
      or twice daily 5-6 days a week for up to 6 weeks. Patients with persistent disease undergo
      salvage resection of the primary tumor and/or neck dissection approximately 3 months after
      the completion of radiotherapy.

      Patients undergo quality of life and swallowing evaluations periodically.

      Patients undergo PET/CT scan at baseline, before beginning radiotherapy, at 6-8 weeks after
      completion of study treatment, every 6 months for 5 years, and then annually thereafter.

      After completion of study treatment, patients are followed at 4 and 8 weeks, every 2 months
      for 2 years, every 3 months for 1 year, and then every 6 months thereafter.
    

Intervention name(s): cetuximab; cisplatin; docetaxel; fluorouracil; computed tomography; positron emission tomography; quality-of-life assessment; 3-dimensional conformal radiation therapy; intensity-modulated radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Procedure; Procedure; Radiation; Radiation
Intervention MeSH terms: Docetaxel; Fluorouracil; Cetuximab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage III verrucous carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; stage IV verrucous carcinoma of the larynx