Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach
- 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.
- 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
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Masking: Open Label, Primary Purpose: Treatment
Objective tumor response rate
Christophe Louvet, MD, PhD
Hopital Saint Antoine
United States: Federal Government