NCT03351296

Two Chemotherapy Regimens Plus or Minus Bevacizumab

Randomized Phase 2 Trial Of Two Chemotherapy Regimens Plus Or Minus Bevacizumab In Patients With Well Differentiated Pancreatic Neuroendocrine Tumors

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	LV5FU2	LV5FU2 (Folinic Acid D, L 400 mg/m² day 1, 5FU 400 mg/m² IV bolus, 5FU 2400 mg/m² 48 hours continuous infusion)
DRUG	Streptozocin	streptozotocin 800 mg/m² day 1 every 14 days
DRUG	Capecitabine	Capecitabine 750 mg/m² twice daily, days 1-14
DRUG	Temozolomide	temozolomide 200 mg/m² once daily, days 10-14, every 28 days
DRUG	Bevacizumab	bevacizumab 5 mg/kg every 14 days

Timeline

• Start date: 2018-06-26
• Primary completion: 2028-12-01
• Completion: 2028-12-01
• First posted: 2017-11-22
• Last updated: 2024-05-08

Locations

20 sites across 1 country: France