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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
streptozotocin 800 mg/m² day 1 every 14 days
Capecitabine 750 mg/m² twice daily, days 1-14
Centre Antoine Lacassagne
Nice, Alpes-Maritimes, France
CHU de Caen
Caen, Calvados, France
Progression Free Survival (PFS) rate
Time frame: Until disease progression or unacceptable toxicity (median 24 months)
Toxicity (NCI-CTCAE 4.0)
Time frame: Until disease progression or unacceptable toxicity
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temozolomide 200 mg/m² once daily, days 10-14, every 28 days
bevacizumab 5 mg/kg every 14 days
CHU de Dijon
Dijon, Côte d'Or, France
Hôpital Haut-Lévêque
Pessac, Gironde, France
IUCT - Hôpital Rangueil
Toulouse, Haute-Garonne, France
Hôpital Beaujon
Clichy, Hauts-de-Seine, France
ICM Val d'Aurelle
Montpellier, Hérault, 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
CHR d'Orléans
Orléans, Loiret, France
...and 10 more locations