S1922 Refractory Small Bowel Adenocarcinoma - Clinical Trial

¿Cuál es el Propósito de este estudio?

We are doing this study to find out if either of 2 different, experimental drug regimens (ramucirumab plus paclitaxel or FOLFIRI) is an option for treating small bowel cancer that has not responded to therapy.

¿Cuál es la Condición que se está estudiando?

Small Bowel Cancer

¿Quién puede participar en el Estudio?

Adults ages 18+ who:

  • Are diagnosed with small bowel carcinoma
  • Have disease that is metastatic or locally advanced and unresectable (cannot be removed by surgery)
  • Did not have success with previous treatment that included fluoropyrimidine and/or oxaliplatin
  • Have never been treated with irinotecan, taxane, or ramurcirumab

For more information about who can join this study, contact the study team at nick.jeffries@duke.edu.

Grupo etario
Adultos

¿Qué Implica?

Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos:

  • Group 1 will take a regimen of ramucirumab every 2 weeks and paclitaxel every week for three weeks followed by a week without treatment. Both drugs are given as an intravenous infusion (IV) through a needle in your vein. The treatment will be repeated every 28 days.
  • Group 2 will get a regimen of FOLFIRI every two weeks as an intravenous infusion (IV) through a needle in your vein. The treatment will be repeated every 28 days. FOLFIRI is a drug combination that uses the following 3 drugs: folinic acid, fluorouracil, and irinotecan hydrochloride.

Detalles del Estudio

Título Completo
S1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Investigador Principal
Especialista en oncología médica
Número de Protocolo
IRB: PRO00115109
NCT: NCT04205968
Fase
Phase II
ClinicalTrials.gov
Estado de inscripción
Abierto para inscripción