Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine
- Determine the objective response rate in patients with chemotherapy naïve relapsed or
metastatic head and neck cancer treated with oxaliplatin and capecitabine.
- Evaluate the safety and toxicity of this regimen in these patients.
- Determine the one-year survival and overall survival of these patients.
OUTLINE: Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice
daily on days 2-15. Treatment repeats every 21 days for up to 6 courses in the absence of
disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 2 years, every
6 months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective response rate (complete response and partial response)
Luis E. Raez, MD, FACP
University of Miami Sylvester Comprehensive Cancer Center
United States: Food and Drug Administration
|University of Miami Sylvester Comprehensive Cancer Center||Miami, Florida 33136|