Efficacy of ABI-007 Plus Gemcitabine or sLV5FU2 as First-line Therapy in Patients With Metastatic Pancreatic Cancer

PHASE2UnknownINTERVENTIONAL
Enrollment

114

Participants

Timeline

Start Date

December 12, 2013

Primary Completion Date

February 28, 2017

Study Completion Date

July 31, 2017

Conditions
Metastatic Pancreatic Cancer
Interventions
DRUG

ABI-007

ABI-007 : 125 mg/m² IV /30min (day 1, day 8, day 15)

DRUG

Gemcitabine

1000 mg/m² IV /30min (day 1, day 8, day 15)

DRUG

simplified LV5FU2

Folinic acid: 400 mg/m² IV /2h (day 1, day 15) Bolus 5-FU: 400 mg/m² IV /15min (day 1, day 15) 5-FU infusion: 2400 mg/m² IV /46h (day 1-2, day 15-16)

Trial Locations (15)

44805

Institut de Cancérologie de l'Ouest - Réné Gauducheau, Saint-Herblain

Unknown

Institut de cancérologie de l'Ouest - Paul Papin, Angers

Institut Sainte Catherine, Avignon

Hôpital Avicenne, Bobigny

Hôpital Beaujon, Clichy

Hôpital Henri Mondor, Créteil

Hôpital Privé Jean Mermoz, Lyon

CHU la Timone, Marseille

Centre Hospitalier Layné, Mont-de-Marsan

Hôpital Européen Georges Pompidou, Paris

Hôpital Pitié-Salpêtrière, Paris

Hôpital Saint Antoine, Paris

Institut Mutualiste Montsouris, Paris

CHU de Reims Hôpital Robert Debré, Reims

Hôpital Trousseau - CHRU Tours, Tours

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celgene Corporation

INDUSTRY

lead

GERCOR - Multidisciplinary Oncology Cooperative Group

OTHER