Docetaxel and Epirubicin as First-Line Therapy in Treating Patients With Locally Advanced or Metastatic Adenocarcinoma of the Stomach
Recruitment status was Active, not recruiting
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of Docetaxel and Epirubicine as First-Line Treatment in Patients With Advanced or Metastatic Adenocarcinoma of the Stomach|
- Objective tumor response rate [ Designated as safety issue: No ]
- Time to tumor progression [ Designated as safety issue: No ]
- Survival without local relapse [ Designated as safety issue: No ]
- Overall survival [ Designated as safety issue: No ]
- Tolerability [ Designated as safety issue: Yes ]
|Study Start Date:||April 2001|
- 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 unacceptable toxicity.
PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075465
|Centre Paul Papin|
|Angers, France, 49036|
|Centre Hospitalier Victor Dupouy|
|Argenteuil, France, 95107|
|Centre Hospital General Robert Ballanger|
|Aulnay Sous Bois, France, 93602|
|Beauvais, France, 60021|
|Bordeaux, France, F-33000|
|Hopital Louis Pasteur|
|Chartres, France, 28018|
|Dijon, France, 21000|
|Hyeres, France, 83400|
|Clinique Victor Hugo|
|Le Mans, France, F-72000|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Hopital de la Croix Rousse|
|Lyon, France, 69317|
|Clinique Saint Jean|
|Lyon, France, 69008|
|CHU de la Timone|
|Marseille, France, 13385|
|Montfermeil, France, 93370|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Hopital Saint Joseph|
|Paris, France, 75674|
|Paris, France, 75970|
|Maison Medicale Marzet|
|Pau, France, 64000|
|Hopital Rene Dubos|
|Pontoise, France, 95300|
|Senlis, France, 60309|
|Hopital d'Instruction des Armes Sainte-Anne|
|Toulon, France, 83800|
|CHRU de Tours - Hopital Trousseau|
|Tours, France, 37044|
|Investigator:||Christophe Louvet, MD, PhD||Hopital Saint Antoine|