Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
- Conditions
- Gastric Cancer
- Registration Number
- NCT00075465
- Lead Sponsor
- GERCOR - Multidisciplinary Oncology Cooperative Group
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Objective tumor response rate Time to tumor progression
- Secondary Outcome Measures
Name Time Method Survival without local relapse Overall survival Tolerability
Trial Locations
- Locations (23)
Centre Paul Papin
🇫🇷Angers, France
Centre Hospitalier Victor Dupouy
🇫🇷Argenteuil, France
Centre Hospital General Robert Ballanger
🇫🇷Aulnay Sous Bois, France
C.H.G. Beauvais
🇫🇷Beauvais, France
Clinique Tivoli
🇫🇷Bordeaux, France
Hopital Louis Pasteur
🇫🇷Chartres, France
Hopital Drevon
🇫🇷Dijon, France
Clinique Sainte-Marguerite
🇫🇷Hyeres, France
Clinique Victor Hugo
🇫🇷Le Mans, France
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
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