Combination Chemotherapy as First-Line Therapy in Treating Patients With Metastatic Pancreatic Cancer
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00112658
- Lead Sponsor
- UNICANCER
- Brief Summary
RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective as first-line therapy in treating pancreatic cancer.
PURPOSE: This randomized phase II/III trial is studying how well combination chemotherapy works as first-line therapy in treating patients with metastatic pancreatic cancer.
- Detailed Description
OBJECTIVES:
Primary
* Compare the objective response rate in patients with metastatic adenocarcinoma of the pancreas treated with oxaliplatin, irinotecan, leucovorin calcium, and fluorouracil vs gemcitabine as first-line chemotherapy. (Phase II)
* Compare the survival of patients treated with these regimens. (Phase III)
Secondary
* Compare the toxicity of these regimens in these patients.
* Compare progression-free survival of patients treated with these regimens. (Phase III)
* Compare the overall response rate in patients treated with these regimens. (Phase III)
* Compare quality of life of patients treated with these regimens. (Phase III)
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive oxaliplatin IV over 2 hours, irinotecan IV over 1½ hours, leucovorin calcium IV over 2 hours, and fluorouracil IV over 5 minutes on day 1 and fluorouracil IV continuously over 46 hours on days 1 and 2. Courses repeat every 14 days.
* Arm II: Patients receive gemcitabine IV on days 1, 8, 15, 22, 29, 36, and 43. Beginning on day 57, patients receive gemcitabine IV once weekly for 3 weeks (days 57, 64, and 71). Courses repeat every 28 days.
PROJECTED ACCRUAL: A total of 348 patients (88 for phase II and 260 for phase III) will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 342
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Folfirinox irinotecan hydrochloride - Folfirinox leucovorin calcium - Folfirinox oxaliplatin - Gemcitabine gemcitabine hydrochloride - Folfirinox fluorouracil -
- Primary Outcome Measures
Name Time Method Objective response rate (Phase II) Survival (Phase III)
- Secondary Outcome Measures
Name Time Method Overall response rate (Phase III) Toxicity Progression-free survival (Phase III) Quality of life (Phase III)
Trial Locations
- Locations (54)
Hopitaux Civils de Colmar
🇫🇷Colmar, France
Clinique Saint Vincent
🇫🇷Epernay, France
Centre Hospitalier General
🇫🇷Belfort, France
Centre Hospitalier Universitaire d'Amiens
🇫🇷Amiens, France
Hopital Saint Andre
🇫🇷Bordeaux, France
Polyclinique des Quatre Pavillons
🇫🇷Lormont, France
Centre Hospitalier Regional de Besancon - Hopital Jean Minjoz
🇫🇷Besancon, France
Hopital Avicenne
🇫🇷Bobigny, France
Hopital Duffaut
🇫🇷Avignon, France
Polyclinique Bordeaux Nord Aquitaine
🇫🇷Bordeaux, France
Institut Bergonie
🇫🇷Bordeaux, France
CHU de Caen
🇫🇷Caen, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
Hopital Ambroise Pare
🇫🇷Marseille, France
Centre Jean Perrin
🇫🇷Clermont-Ferrand, France
Centre Regional Francois Baclesse
🇫🇷Caen, France
Centre Hospitalier Universitaire Henri Mondor
🇫🇷Creteil, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Centre Hospitalier Departemental
🇫🇷La Roche Sur Yon, France
CHR Clermont Ferrand, Hotel Dieu
🇫🇷Clermont-Ferrand, France
Hopital Du Bocage
🇫🇷Dijon, France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
🇫🇷Elbeuf, France
CMC Les Ormeaux
🇫🇷Le Havre, France
Centre Oscar Lambret
🇫🇷Lille, France
Centre Rene Huguenin
🇫🇷Saint Cloud, France
Hopital Saint Vincent de Paul
🇫🇷Lille, France
Hopital de la Croix Rousse
🇫🇷Lyon, France
Centre Leon Berard
🇫🇷Lyon, France
Hopital Edouard Herriot - Lyon
🇫🇷Lyon, France
CHU de la Timone
🇫🇷Marseille, France
CHU Nord
🇫🇷Marseille, France
Hopital Notre-Dame de Bon Secours
🇫🇷Metz, France
Centre Hospitalier General de Mont de Marsan
🇫🇷Mont-de-Marsan, France
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
🇫🇷Montpellier, France
Hopital Saint Michel
🇫🇷Paris, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Centre Regional Rene Gauducheau
🇫🇷Nantes-Saint Herblain, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Centre Hospitalier de Perpignan
🇫🇷Perpignan, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre Benite, France
Centre Eugene Marquis
🇫🇷Rennes, France
Institut Jean Godinot
🇫🇷Reims, France
CHU - Robert Debre
🇫🇷Reims, France
Centre Paul Strauss
🇫🇷Strasbourg, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Clinique Charcot
🇫🇷Sainte Foy Les Lyon, France
Centre Hospitalier de Semur en Auxois
🇫🇷Semur en Auxois, France
CHU de Tours
🇫🇷Tours, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Institut Claudius Regaud
🇫🇷Toulouse, France
Centre Hospitalier de Tarbes
🇫🇷Tarbes, France
Centre Alexis Vautrin
🇫🇷Vandoeuvre-les-Nancy, France
Institut Gustave Roussy
🇫🇷Villejuif, France