Combination Chemotherapy in Treating Patients With Metastatic Pancreatic Cancer That Cannot Be Removed By Surgery
- Conditions
- Pancreatic Cancer
- Interventions
- Registration Number
- NCT00303758
- Lead Sponsor
- Federation Francophone de Cancerologie Digestive
- Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fluorouracil, leucovorin, cisplatin, and gemcitabine, 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) and giving them in different ways may kill more tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating metastatic pancreatic cancer.
PURPOSE: This randomized phase III trial is studying two different combination chemotherapy regimens to compare how well they work in treating patients with metastatic pancreatic cancer that cannot be removed by surgery.
- Detailed Description
OBJECTIVES:
Primary
* Compare the overall survival of patients with unresectable metastatic pancreatic cancer treated with fluorouracil, leucovorin calcium, and cisplatin followed by gemcitabine hydrochloride vs gemcitabine hydrochloride followed by fluorouracil, leucovorin calcium, and cisplatin.
Secondary
* Compare progression-free survival of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
* Compare the quality of life of patients treated with these regimens.
* Compare the percentage of these patients needing second-line therapy.
* Compare the duration of hospitalization of patients treated with these regimens.
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to ECOG performance status (0 or 1 vs 2), participating center, location of the tumor (ampullar region vs other locations), and infusion rate of gemcitabine hydrochloride (30 vs 100 minutes). Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive leucovorin calcium IV over 2 hours on day 1, cisplatin IV over 1 hour on day 1 or 2, and fluorouracil IV over 46 hours on day 1 and 2. Treatment repeats every 2 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression also receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks. Patients then receive gemcitabine hydrochloride IV on days 1, 8, and 15. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive gemcitabine hydrochloride IV over 30 or 100 minutes weekly for 7 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression receive fluorouracil, leucovorin calcium, and cisplatin as in arm I.
Quality of life is assessed at baseline and then every 2 months.
After completion of study therapy, patients are followed periodically for 2 years.
PROJECTED ACCRUAL: A total of 202 patients will be accrued for this study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LV5FU2 simplifié + cisplatine puis gemcitabine si progression leucovorin calcium LV5FU2 simplifié + cisplatine puis gemcitabine si progression gemcitabine puis LV5FU2 simplifié + cisplatine si progression cisplatin gemcitabine puis LV5FU2 simplifié + cisplatine si progression LV5FU2 simplifié + cisplatine puis gemcitabine si progression gemcitabine hydrochloride LV5FU2 simplifié + cisplatine puis gemcitabine si progression gemcitabine puis LV5FU2 simplifié + cisplatine si progression fluorouracil gemcitabine puis LV5FU2 simplifié + cisplatine si progression LV5FU2 simplifié + cisplatine puis gemcitabine si progression cisplatin LV5FU2 simplifié + cisplatine puis gemcitabine si progression LV5FU2 simplifié + cisplatine puis gemcitabine si progression fluorouracil LV5FU2 simplifié + cisplatine puis gemcitabine si progression gemcitabine puis LV5FU2 simplifié + cisplatine si progression gemcitabine hydrochloride gemcitabine puis LV5FU2 simplifié + cisplatine si progression gemcitabine puis LV5FU2 simplifié + cisplatine si progression leucovorin calcium gemcitabine puis LV5FU2 simplifié + cisplatine si progression
- Primary Outcome Measures
Name Time Method Overall survival 2012
- Secondary Outcome Measures
Name Time Method Progression-free survival 2012 Quality of life 2012 Percentage of patients needing second-line therapy 2012 Duration of hospitalization 2012 Toxicity 2012
Trial Locations
- Locations (46)
Centre Hospital Universitaire Hop Huriez
🇫🇷Lille, France
Centre Hospitalier de Chalons-en-Champagne
🇫🇷Chalons-en-Champagne, France
Hopital Saint Joseph
🇫🇷Marseille, France
C.H. Bourg En Bresse
🇫🇷Bourg En Bresse, France
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
🇫🇷Dijon, France
Clinique Pasteur
🇫🇷Guilherand Granges, France
Centre Hospitalier d'Abbeville
🇫🇷Abbeville, France
Centre Hospitalier Pierre Oudot
🇫🇷Bourgoin-Jallieu, France
Centre Hospitalier de Semur en Auxois
🇫🇷Semur en Auxois, 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
CHR Hotel Dieu
🇫🇷Nantes, France
Hopital Duffaut
🇫🇷Avignon, France
Hopital Beaujon
🇫🇷Clichy, France
Centre Hospitalier Intercommunal St. Aubin les Elbeuf
🇫🇷Elbeuf, France
Hopital Robert Boulin
🇫🇷Libourne, France
Centre Hospitalier de Martigues
🇫🇷Martigues, France
CHR D'Orleans - Hopital de la Source
🇫🇷Orleans, France
Hopital Bichat - Claude Bernard
🇫🇷Paris, France
Centre Hospitalier de Blois
🇫🇷Blois, France
CHU de Grenoble - Hopital de la Tronche
🇫🇷Grenoble, France
Centre Hospitalier Universitaire Ambroise Pare - Boulogne
🇫🇷Boulogne, France
Hopital Louis Pasteur
🇫🇷Colmar, France
Hopital Du Bocage
🇫🇷Dijon, France
Centre Hospitalier De Dunkerque - CHD
🇫🇷Dunkerque, France
CHR Clermont Ferrand, Hotel dieu
🇫🇷Clermont-Ferrand, France
Clinique Ste - Marie
🇫🇷Pontoise, France
Hopital Charles Nicolle
🇫🇷Rouen, France
Centre Hospitalier Regional et Universitaire de Lille
🇫🇷Lille, France
Hopital Edouard Herriot
🇫🇷Lyon, France
CHU de la Timone
🇫🇷Marseille, France
Hopital Europeen Georges Pompidou
🇫🇷Paris, France
Hopital Haut Leveque
🇫🇷Pessac, France
Centre Eugene Marquis
🇫🇷Rennes, France
Centre Joliot Curie Des Docteurs Jean-Christophe Chardon Jacques Hernandez Et Laurent Gasnault
🇫🇷Saint Martin Boulogne, France
Centre Hospitalier de Tarbes
🇫🇷Tarbes, France
Centre Hospitalier Universitaire d'Amiens
🇫🇷Caen, France
Centre Hospitalier Docteur Duchenne
🇫🇷Boulogne Sur Mer, France
CHU Nord
🇫🇷Marseille, France
Centre Hospitalier de Soissons
🇫🇷Soissons cedex, France
Nouvelle Clinique Generale
🇫🇷Valence, France
CHU - Robert Debre
🇫🇷Reims, France
Centre Hospitalier Draguignan
🇫🇷Draguignan, France
Clinique Armoricaine De Radiologie
🇫🇷Saint Brieuc, France
Hopital Universitaire Hautepierre
🇫🇷Strasbourg, France
Centre Hospitalier de Saint-Quentin
🇫🇷Saint-Quentin, France