Cisplatin With or Without Monoclonal Antibody Therapy in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
      so they stop growing or die. Monoclonal antibodies can locate cancer cells and either kill
      them or deliver tumor-killing substances to them without harming normal cells. It is not yet
      known whether cisplatin plus monoclonal antibody therapy is more effective than cisplatin
      alone for metastatic or recurrent head and neck cancer.

      PURPOSE: Randomized double-blinded phase III trial to compare the effectiveness of cisplatin
      with or without monoclonal antibody in treating patients who have metastatic or recurrent
      head and neck cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy (survival and response rates) and toxicity of cisplatin
      with or without monoclonal antibody C225 in patients with metastatic and/or recurrent
      squamous cell head and neck cancer. II. Compare the correlation between epidermal growth
      factor receptor density and response and progression-free survival in these patients. III.
      Determine the steady state serum levels of monoclonal antibody C225 and the frequency of
      human antibody response to this monoclonal antibody in patients treated with the combination
      therapy.

      OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
      stratified according to disease status (newly diagnosed vs recurrent) and ECOG status (0 vs
      1). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive monoclonal
      antibody C225 IV over 2 hours followed 1 hour later by cisplatin IV over 2 hours on day 1 of
      course 1. Monoclonal antibody C225 is administered over 1 hour on subsequent courses. Arm II:
      Patients receive placebo IV over 2 hours followed 1 hour later by cisplatin as in arm I on
      day 1 of course 1. Placebo is administered over 1 hour on subsequent courses. Treatment
      continues every 4 weeks for at least 6 courses in the absence of disease progression or
      unacceptable toxicity. Arm II patients who develop disease progression may then crossover to
      arm I treatment. Patients are followed at 1 and 3 months and then every 3 months until
      disease progression.

      PROJECTED ACCRUAL: A total of 114 patients will be accrued for this study within 14 months.
    

Intervention name(s): cetuximab; cisplatin
Intervention type(s): Biological; Drug
Intervention MeSH terms: Cetuximab
Allocation: Randomized
Primary purpose: Treatment
Keywords: untreated metastatic squamous neck cancer with occult primary; recurrent metastatic squamous neck cancer with occult primary; stage III squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage III squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage III squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage III squamous cell carcinoma of the larynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; stage III squamous cell carcinoma of the paranasal sinus and nasal cavity; stage IV squamous cell carcinoma of the paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of the paranasal sinus and nasal cavity