Phase II Trial Of Weekly Irinotecan And Docetaxel In Recurrent Or Metastatic Head And Neck Carcinoma

Brief Summary

Detailed Description

OBJECTIVES: * Determine the response rate in patients with metastatic or locally recurrent head and neck cancer treated with irinotecan and docetaxel. * Determine the progression-free and overall survival of patients treated with this regimen. * Determine the toxic effects of this regimen in these patients. * Correlate angiogenesis markers and cyclooxygenase-2 expression with response and survival in patients treated with this regimen. * Correlate UGT1A1 genotype with the toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior chemotherapy (no prior chemotherapy for locally recurrent or metastatic disease or more than 6 months since prior chemotherapy as primary therapy vs 1 prior chemotherapy regimen for locally recurrent or metastatic disease or less than 6 months since prior chemotherapy as primary therapy). Patients receive docetaxel IV over 60 minutes followed by irinotecan IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 32-72 patients (16-36 per stratum) will be accrued for this study within 6-14 months.

Primary Outcomes

Not specified