Gastric Cancer Clinical Trial
Official title:
A Phase II Study of XELOX in Locally Advanced or Metastatic Gastric Cancer
RATIONALE: Drugs used in chemotherapy, such as capecitabine and oxaliplatin, 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 capecitabine together with
oxaliplatin works in treating patients with locally advanced, unresectable, or metastatic
stomach cancer.
OBJECTIVES:
Primary
- Determine the response proportion in patients with locally advanced, unresectable, or
metastatic gastric cancer treated with capecitabine and oxaliplatin.
Secondary
- Determine the tolerability and toxicity of this regimen in these patients.
- Determine the median and progression-free survival of patients treated with this
regimen.
OUTLINE: This is an open-label study.
Patients receive oxaliplatin IV over 2 hours on day 1 and oral capecitabine twice daily on
days 1-7. Treatment repeats every 14 days in the absence of unacceptable toxicity or disease
progression.
After completion of study treatment, patients are followed every 3 months for 1 year, every 6
months for 2 years, and then annually thereafter.
PROJECTED ACCRUAL: A total of 46 patients will be accrued for this study.
;
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