Two Chemotherapy Regimens Plus or Minus Bevacizumab

Phase 2

Active, not recruiting

• Conditions: Pancreatic Cancer
• Interventions: Drug: LV5FU2; Drug: Capecitabine; Drug: Streptozocin; Drug: Temozolomide; Drug: Bevacizumab

• Registration Number: NCT03351296
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

Compare the effect of capecitabine (cape) + temozolomide (temo) and of 5FU + streptozotocin (strepto) given with a new schedule (LV5FU2 + strepto), two of the most used chemotherapy regimens in the treatment of well differentiated pancreatic neuroendocrine tumors alone or in combination with bevacizumab (beva) on progression-free survival (PFS) and compare the chemotherapy regimens alone or with beva (two by two design) on the same criteria.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-11-20
• Study First Submitted QC: 2017-11-20
• Study First Posted: 2017-11-22
• Study Start: 2018-06-26
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-07
• Last Update Posted: 2024-05-08
• Primary Completion: 2028-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LV5FU2 + streptozotocin + Bevacizumab	LV5FU2	-
Capecitabine + temozolomide + Bevacizumab	Capecitabine	-
LV5FU2 + streptozotocin	LV5FU2	-
Capecitabine + temozolomide	Capecitabine	-
LV5FU2 + streptozotocin	Streptozocin	-
Capecitabine + temozolomide	Temozolomide	-
LV5FU2 + streptozotocin + Bevacizumab	Streptozocin	-
LV5FU2 + streptozotocin + Bevacizumab	Bevacizumab	-
Capecitabine + temozolomide + Bevacizumab	Temozolomide	-
Capecitabine + temozolomide + Bevacizumab	Bevacizumab	-

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS) rate	Until disease progression or unacceptable toxicity (median 24 months)

Secondary Outcome Measures

Name	Time	Method
Toxicity (NCI-CTCAE 4.0)	Until disease progression or unacceptable toxicity

Trial Locations

Locations (19)

Gustave Roussy; 🇫🇷 Villejuif, Val De Marne, France

CHU de Caen; 🇫🇷 Caen, Calvados, France

ICM Val d'Aurelle; 🇫🇷 Montpellier, Hérault, France

CHU Angers; 🇫🇷 Angers, Maine-et-Loire, France

Institut de Cancérologie de Lorraine; 🇫🇷 Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France

Centre Antoine Lacassagne; 🇫🇷 Nice, Alpes-Maritimes, France

CHU de Dijon; 🇫🇷 Dijon, Côte d'Or, France

Hôpital Haut-Lévêque; 🇫🇷 Reims, Marne, France

IUCT - Hôpital Rangueil; 🇫🇷 Toulouse, Haute-Garonne, France

Hôpital Beaujon; 🇫🇷 Clichy, Hauts-de-Seine, France

Hôpital Trousseau CHU Tours; 🇫🇷 Chambray-lès-Tours, Indre-et-Loire, France

Institut de Cancérologie de l'Ouest site René Gauducheau; 🇫🇷 Saint-Herblain, Loire-Atlantique, France

Hôpital Saint-Antoine; 🇫🇷 Paris, France

CHR d'Orléans; 🇫🇷 Orléans, Loiret, France

Hôpital Edouard Herriot; 🇫🇷 Lyon, Rhône, France

Hôpital Croix St Simon; 🇫🇷 Paris, France

Hôpital Européen Georges Pompidou; 🇫🇷 Paris, France

Hôpital Cochin; 🇫🇷 Paris, France

Centre Eugène Marquis; 🇫🇷 Rennes, Île-et-Vilaine, France