drugset / Trial / NCT04205968

Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers

NCT04205968

RandomizedParallel-groupOpen-labelTreatment

Summary

This phase II trial studies how well ramucirumab and paclitaxel or the FOLFIRI regimen (leucovorin calcium, fluorouracil, and irinotecan hydrochloride) work in treating patients with small bowel cancers that have spread extensively to other anatomic sites (advanced) or are no longer responding to treatment (refractory). Ramucirumab is a monoclonal antibody that attaches to and inhibits a molecule called VEGFR-2. This may restrain new blood vessel formation therefore reducing nutrient supply to tumor which may interfere with tumor cell growth and expansion. Drugs used in chemotherapy, such as paclitaxel, leucovorin calcium, fluorouracil, and irinotecan hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving Ramucirumab plus paclitaxel or FOLFIRI, may be helpful in treating advanced or refractory small bowel cancers and may help patients live longer.

Timeline

Start
2020-06-01
Primary completion
2026-08-01
Completion
2027-08-01

Drugs

EvaluationDrugModalityDoseRoute
Subject Irinotecan Small molecule Intravenous
Subject Leucovorin Small molecule Intravenous
Subject Paclitaxel Small molecule Intravenous
Subject Ramucirumab Monoclonal antibody Intravenous
Subject fluorouracil Small molecule Intravenous