Gastric Cancer Clinical Trial
Official title:
A Phase II Study Of Docetaxel And Capecitabine In Patients With Measurable Metastatic Adenocarcinoma Of The Stomach And Gastroesophageal Junction
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study of the effectiveness of combining docetaxel with
capecitabine in treating patients who have metastatic cancer of the stomach or
gastroesophageal junction.
OBJECTIVES:
- Determine the objective tumor response rate in patients with metastatic gastric or
gastroesophageal junction adenocarcinoma treated with docetaxel and capecitabine.
- Determine the time to progression in patients treated with this regimen.
- Determine the overall survival in patients treated with this regimen.
- Determine the toxic effects of this regimen in these patients.
- Determine whether interleukin-1 polymorphisms are present among patients who have
weight loss vs no weight loss, and their relationship to a poor prognosis.
- Assess the quality of life and swallowing uniscale during chemotherapy in these
patients.
OUTLINE: Patients receive docetaxel IV over 1 hour on day 1 and oral capecitabine twice
daily on days 1-14. Courses repeat every 21 days for up to 2 years in the absence of disease
progression or unacceptable toxicity.
Quality of life is assessed at baseline, at each tumor measurement, and at the end of
treatment.
Patients are followed every 3 months until disease progression and then every 6 months until
3 years from registration.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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