First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI

PHASE2CompletedINTERVENTIONAL
Enrollment

288

Participants

Timeline

Start Date

November 16, 2018

Primary Completion Date

January 10, 2025

Study Completion Date

January 10, 2025

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

Irinotecan Liposomal Injection

Nal-IRI at 80 mg/m2 IV over 90 minutes

DRUG

5-FU/LV

5-FU 2400 mg/m2 IV over 46-hours, every 2 weeks.

DRUG

Nab-Paclitaxel

Nab-Paclitaxel: 125 mg/m2 This treatment is administered at D1, D8, D15 and at D29, D36, D43.

DRUG

Gemcitabine

1000 mg/m² in 500 ml normal saline infusion at a fixed dose rate of 10 mg/m²/min (i.e. 100 min). This treatment is administered at D1, D8, D15 and at D29, D36, D43.

Trial Locations (36)

12000

CH Jacques Puel, Rodez

13000

Hôpital Européen, Marseille

Institut Paoli Calmettes, Marseille

21000

Centre GF Leclerc, Dijon

CHU, Dijon

Institut de cancérologie de Bourgogne, Dijon

22190

Centre Cario HPCA, Plérin

30000

Centre médical Oncogard, Nîmes

43000

Hôpital Emile Roux, Le Puy-en-Velay

49000

CHU Hôtel Dieu, Angers

54500

CHRU de Nancy, Vandœuvre-lès-Nancy

62200

CH Duchenne, Boulogne-sur-Mer

62218

CH Docteur Schaffner, Lens

63000

CHU Estaing, Clermont-Ferrand

64100

CH de la Côte Basque, Bayonne

66000

CH Saint Jean, Perpignan

68026

Hopitaux civils de Colmar, Colmar

69000

Clinique privée Jean Mermoz, Lyon

71100

Hôpital Privé Sainte Marie, Chalon-sur-Saône

75013

Groupe Hospitalier La Pitié Salpêtrière, Paris

75679

Hôpital Cochin, Paris

75970

Hôpital Tenon, Paris

76000

CHU Charles Nicolle, Rouen

77100

CH, Meaux

79000

CH, Niort

80000

Clinique privée de l'Europe, Amiens

87000

CHU Dupuytren, Limoges

89000

CH, Auxerre

91100

CH Sud Francilien, Corbeil-Essonnes

91160

CH, Longjumeau

92150

CH Foch, Suresnes

92160

Hôpital privé, Antony

93022

CHU Avicenne, Bobigny

95520

CH Privé Sainte Marie, Osny

97200

CHU Clarac, Fort-de-France

Unknown

Hopital Européen Georges Pompidou, Paris

All Listed Sponsors
lead

Federation Francophone de Cancerologie Digestive

OTHER

NCT03693677 - First Line Metastatic Pancreatic Cancer : 5FU/LV+Nal-IRI, Gemcitabine+Nab-paclitaxel or a Sequential Regimen of 2 Months 5FU/LV+Nal-IRI | Biotech Hunter | Biotech Hunter