Gastric Cancer Clinical Trial
Official title:
Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
RATIONALE: Drugs used in chemotherapy, such as docetaxel and epirubicin, work in different
ways to stop tumor cells from dividing so they stop growing or die. Giving more than one
drug may kill more tumor cells.
PURPOSE: This phase II trial is studying how well giving docetaxel together with epirubicin
as first-line therapy works in treating patients with locally advanced or metastatic
adenocarcinoma (cancer) of the stomach.
OBJECTIVES:
Primary
- Determine the objective tumor response rate and time to tumor progression in patients
with locally advanced or metastatic adenocarcinoma of the stomach treated with
docetaxel and epirubicin as first-line therapy.
Secondary
- Determine the survival without local relapse and overall survival of patients treated
with this regimen.
- Determine the tolerance to this regimen in these patients.
OUTLINE: This is an open-label, multicenter study.
Patients receive epirubicin IV over 30 minutes and docetaxel IV over 1 hour on day 1.
Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or
unacceptable toxicity.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
;
Masking: Open Label, Primary Purpose: Treatment
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