Erlotinib and Cisplatin in Treating Patients With Recurrent or Metastatic Head and Neck Cancer
Condition: Head and Neck Cancer
MeSH terms: Head and Neck Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      RATIONALE: Biological therapies such as erlotinib may interfere with the growth of tumor
      cells and slow the growth of the tumor. Drugs used in chemotherapy use different ways to stop
      tumor cells from dividing so they stop growing or die. Combining erlotinib with cisplatin may
      kill more tumor cells.

      PURPOSE: Phase I/II trial to study the effectiveness of combining erlotinib and cisplatin in
      treating patients who have recurrent or metastatic head and neck cancer.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the objective response rate in patients with recurrent or metastatic squamous
           cell cancer of the head and neck treated with erlotinib and cisplatin.

        -  Determine the stable disease rates, duration of response, progression-free survival,
           median survival, and overall survival of patients treated with this regimen.

        -  Determine the safety and tolerability of this regimen in these patients.

        -  Determine the relationship between clinical, pharmacokinetic, and pharmacodynamic
           effects of this regimen in these patients.

        -  Correlate baseline and post-treatment levels of epidermal growth factor receptor, its
           downstream signaling components, and markers of angiogenesis and apoptosis in tumor and
           skin biopsies with clinical outcome in patients treated with this regimen.

      OUTLINE: This is a dose-escalation, multicenter study.

      Patients receive oral erlotinib once daily on days -6 to 21 for the first course only and
      cisplatin IV over 60 minutes on day 1. For the second and subsequent courses, patients
      receive oral erlotinib once daily on days 1-21 and cisplatin as in course 1. Treatment
      repeats every 21 days for up to 6 courses in the absence of disease progression or
      unacceptable toxicity. Patients with stable or responding disease after 6 courses may
      continue to receive erlotinib alone until disease progression.

      Cohorts of 3-6 patients receive escalating doses of erlotinib and cisplatin until the maximum
      tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2
      of 3 or 2 of 6 patients experience dose-limiting toxicity. At least 6 patients are treated at
      the MTD.

      Patients are followed every 3 months.

      PROJECTED ACCRUAL: A maximum of 43 patients will be accrued for this study within 18 months.
    

Intervention name(s): cisplatin; erlotinib hydrochloride
Intervention type(s): Drug; Drug
Intervention MeSH terms: Erlotinib Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent metastatic squamous neck cancer occult primary; neck cancer with occult primary squamous carcinoma; stage IV squamous cell carcinoma of the lip and oral cavity; recurrent squamous cell carcinoma of the lip and oral cavity; stage IV squamous cell carcinoma of the oropharynx; recurrent squamous cell carcinoma of the oropharynx; stage IV squamous cell carcinoma of the nasopharynx; recurrent squamous cell carcinoma of the nasopharynx; stage IV squamous cell carcinoma of the hypopharynx; recurrent squamous cell carcinoma of the hypopharynx; stage IV squamous cell carcinoma of the larynx; recurrent squamous cell carcinoma of the larynx; squamous cell carcinoma of paranasal sinus and nasal cavity; recurrent squamous cell carcinoma of sinus and nasal cavity