Chemotherapy and Radiation Therapy in Treating Patients With Stage III or Stage IV Larynx or Oropharynx Cancer
Condition: Head and Neck Cancer
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use 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.
      Combining chemotherapy with radiation therapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by
      radiation therapy and chemotherapy in treating patients who have stage III or stage IV cancer
      of the larynx or stage III or stage IV cancer of the oropharynx.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the organ preservation rate in patients with stage III or IV squamous cell
           carcinoma of the larynx or oropharynx treated with paclitaxel and carboplatin followed
           by paclitaxel with concurrent radiotherapy.

        -  Determine the feasibility and toxicity of this regimen in these patients.

        -  Determine the utility of pre- and post-treatment organ function instruments on
           swallowing ability and voice quality in patients treated with this regimen.

        -  Determine the disease-free survival and patterns of failure of patients treated with
           this regimen.

        -  Determine the objective tumor response rate (complete and partial response) in these
           patients following treatment with 2 courses of induction therapy with paclitaxel and
           carboplatin.

        -  Determine changes in quality of life of patients treated with this regimen.

        -  Determine whether the presence of human papilloma virus infection and p-glycoprotein
           correlates with outcome in patients treated with this regimen.

      OUTLINE: This is a multicenter study. Patients are stratified according to disease site
      (larynx vs oropharynx).

      Patients receive induction therapy comprising paclitaxel IV over 3 hours followed by
      carboplatin IV over 30-60 minutes on days 1 and 22. Within 28 days after completion of
      induction therapy, patients with responding or stable disease receive paclitaxel IV over 60
      minutes on days 1, 8, 15, 22, 29, 36, and 43 and radiotherapy once daily, 5 times weekly, for
      7 weeks beginning on day 1.

      Within 6-8 weeks after completion of therapy, patients who initially had bulky neck disease
      (N3) or who have residual palpable lymphadenopathy undergo surgical neck dissection. Patients
      with N1-N2 disease with complete response may also undergo neck dissection. Patients with
      initial complete response who recur at the primary site undergo surgical salvage.

      Quality of life is assessed at baseline, after induction therapy, and at 3, 12, and 24 months
      after completion of all therapy.

      Patients are followed at 6 weeks, 3 months, every 6-8 weeks for 1 year, every 3 months for 1
      year, every 4 months for 1 year, and then every 6 months for 5 years thereafter.

      PROJECTED ACCRUAL: A total of 110 patients (55 per stratum) will be accrued for this study.
    

Intervention name(s): carboplatin; paclitaxel; conventional surgery; radiation therapy
Intervention type(s): Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Paclitaxel; Carboplatin
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 larynx; stage IV squamous cell carcinoma of the larynx