drugset / Trial / NCT03351296
Two Chemotherapy Regimens Plus or Minus Bevacizumab
Phase 2
Active not recruiting
140 enrolled
Gustave Roussy, Cancer Campus, Grand Paris
National Cancer Institute, France · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2018-06-26
- Primary completion
- 2028-12
- Completion
- 2028-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bevacizumab | Monoclonal antibody | 5 mg/kg | — |
| Subject | Capecitabine | Small molecule | 750 mg/m2 | — |
| Subject | Folinic Acid D, L | Unknown | 400 mg/m2 | — |
| Subject | Temozolomide | Small molecule | 200 mg/m2 | — |
| Subject | fluorouracil | Small molecule | 400 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 2400 mg/m2 | Intravenous |
| Subject | streptozocin | Small molecule | 800 mg/m2 | — |