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.
Who Can Participate?
Eligibility
Adults ages 18+ who:<ul>
<li>Are diagnosed with small bowel carcinoma</li>
<li>Have disease that is metastatic or locally advanced and unresectable (cannot be removed by surgery)</li>
<li>Did not have success with previous treatment that included fluoropyrimidine and/or oxaliplatin</li>
<li>Have never been treated with irinotecan, taxane, or ramurcirumab</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
<li>Are diagnosed with small bowel carcinoma</li>
<li>Have disease that is metastatic or locally advanced and unresectable (cannot be removed by surgery)</li>
<li>Did not have success with previous treatment that included fluoropyrimidine and/or oxaliplatin</li>
<li>Have never been treated with irinotecan, taxane, or ramurcirumab</li></ul>
For more information about who can join this study, contact the study team at <a href= "mailto: nick.jeffries@duke.edu">nick.jeffries@duke.edu.</a>
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:<ul>
<li>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.</li>
<li>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.</li></ul>
<li>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.</li>
<li>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.</li></ul>
Study Details
Full Title
S1922: Randomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma
Principal Investigator
Aman
Opneja
Protocol Number
PRO00115109
NCT ID
NCT04205968
Phase
II
Enrollment Status
Open to Enrollment