Gemcitabine With or Without Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Unresectable Pancreatic Adenocarcinoma
Recruitment status was Active, not recruiting
RATIONALE: Drugs used in chemotherapy, such as gemcitabine and oxaliplatin, work in different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether gemcitabine is more effective with or without oxaliplatin in treating pancreatic adenocarcinoma.
PURPOSE: This randomized phase III trial is studying gemcitabine and oxaliplatin to see how well they work compared to gemcitabine alone in treating patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma.
Drug: gemcitabine hydrochloride
|Study Design:||Allocation: Randomized
Primary Purpose: Treatment
|Official Title:||Phase III Randomized Study Of Gemcitabine Versus Gemcitabine-Oxaliplatine In Patients With Locally Advanced Or Metastatic Pancreatic Carcinoma|
- Overall survival [ Designated as safety issue: No ]
- Time to response [ Designated as safety issue: No ]
- Clinical benefit [ Designated as safety issue: No ]
- Quality of life [ Designated as safety issue: No ]
- Progression-free survival [ Designated as safety issue: No ]
|Study Start Date:||November 2003|
- Compare the overall survival of patients with locally advanced or metastatic unresectable pancreatic adenocarcinoma treated with gemcitabine with or without oxaliplatin.
- Compare the time of response in patients treated with these regimens.
- Compare the clinical benefit of and tolerance to these regimens in these patients.
- Compare the quality of life of patients treated with these regimens.
- Compare the progression-free survival of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to participating center, ECOG performance status (0 or 1 vs 2), and extent of disease (locally advanced vs metastatic). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive gemcitabine IV over 30 minutes once weekly on weeks 1-7 and 9-11 in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive gemcitabine IV over 100 minutes on day 1 and oxaliplatin IV over 2 hours on day 2. Courses repeat every 14 days for up to 3 months in the absence of disease progression or unacceptable toxicity.
After the completion of chemotherapy, patients with locally advanced disease receive chemoradiotherapy.
Quality of life is assessed at baseline and then every 2 months.
PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this study within 24 months.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00075452
|Centre Paul Papin|
|Angers, France, 49036|
|Beauvais, France, 60021|
|Hopital Saint Andre|
|Bordeaux, France, 33075|
|CHU Ambroise Pare|
|Boulogne Billancourt, France, F-92104|
|Briis Sous Forges, France, 91640|
|Hopital Louis Pasteur|
|Chartres, France, 28018|
|Chu-Hopital Gabriel Montpied|
|Clermont Ferrand, France, F-63000|
|Clichy, France, 92118|
|Hopital Louis Mourier|
|Colombes, France, F-92701|
|Dijon, France, 21000|
|Centre Hospitalier Departemental|
|La Roche Sur Yon, France, F-85025|
|Hopital Saint - Louis|
|La Rochelle, France, 17000|
|Centre Hospitalier de Lagny|
|Lagny Sur Marne, France, 77405|
|Hopital Andre Mignot|
|Le Chesnay, France, 78157|
|C. H. Du Mans|
|Le Mans, France, 72037|
|Centre Jean Bernard|
|Le Mans, France, 72000|
|Hopital Robert Boulin|
|Libourne, France, 33500|
|Centre Hospital Universitaire Hop Huriez|
|Lille, France, 59037|
|Clinique Saint Jean|
|Lyon, France, 69008|
|Hopital de la Croix Rousse|
|Lyon, France, 69317|
|Hopital Notre-Dame de Bon Secours|
|Metz, France, 57038|
|Montfermeil, France, 93370|
|American Hospital of Paris|
|Neuilly Sur Seine, France, F-92202|
|Hopital de la Croix St. Simon|
|Paris, France, 75020|
|Hopital Bichat - Claude Bernard|
|Paris, France, 75018|
|Paris, France, 75651|
|Hopital Europeen Georges Pompidou|
|Paris, France, 75015|
|Hopital Saint Antoine|
|Paris, France, 75571|
|Paris, France, 75475|
|Paris, France, 75970|
|Maison Medicale Marzet|
|Pau, France, 64000|
|Hopital Haut Leveque|
|Pessac, France, 33604|
|Centre Hospitalier Lyon Sud|
|Pierre Benite, France, 69495|
|Clinique Ste - Marie|
|Pontoise, France, 95300|
|Polyclinique De Courlancy|
|Reims, France, F-51100|
|C. H. De Saumur|
|Saumur, France, 49403|
|Senlis, France, 60309|
|Institut Gustave Roussy|
|Villejuif, France, F-94805|
|Investigator:||Christophe Louvet, MD, PhD||Hopital Saint Antoine|