S1922 Refractory Small Bowel Adenocarcinoma - Clinical Trial
What is the Purpose of this Study?
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.
What is the Condition Being Studied?
Small Bowel Cancer
Who Can Participate in the Study?
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.
Age Group
Adults
What is Involved?
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- 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.
Study Details
Full Title
S1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Principal Investigator
Medical Oncologist
Protocol Number
IRB:
PRO00115109
NCT:
NCT04205968
Phase
Phase
II
ClinicalTrials.gov
View on ClinicalTrials.gov
Enrollment Status
Open for Enrollment