Head and Neck Cancer Clinical Trial
Official title:
Treatment of Relapsed or Metastatic Head and Neck Carcinomas With Oxaliplatin and Capecitabine
RATIONALE: Drugs used in chemotherapy, such as oxaliplatin and capecitabine, work in
different ways to stop the growth of tumor cells, either by killing the cells or by stopping
them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor
cells.
PURPOSE: This phase II trial is studying how well giving oxaliplatin together with
capecitabine works in treating patients with relapsed or metastatic head and neck cancer.
OBJECTIVES:
Primary
- Determine the objective response rate in patients with chemotherapy naïve relapsed or
metastatic head and neck cancer treated with oxaliplatin and capecitabine.
Secondary
- 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
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