About this trial
This clinical trial looks at how well two different treatments work for patients with advanced small bowel cancers. These cancers have either spread to other parts of the body or are not responding to previous treatments. One treatment combines ramucirumab and paclitaxel, while the other uses a combination called FOLFIRI. The goal is to find out which treatment helps patients live longer and feel better.
The trial ID is NCT04205968. This is a Phase 2 study, meaning it is looking at how well the treatments work and their safety. It is regulated by the FDA, and about 94 people are expected to take part.
Who can join
This trial is open to adults aged 18 and older, including both men and women. Participants must have a confirmed diagnosis of small bowel adenocarcinoma and have received prior treatments. Some health criteria must be met, such as stable blood counts and no recent major surgeries. The trial team will check to confirm who can join.
Conditions
Metastatic Small Intestinal Adenocarcinoma, Stage III Small Intestinal Adenocarcinoma AJCC v8, Stage IIIA Small Intestinal Adenocarcinoma AJCC v8, Stage IIIB Small Intestinal Adenocarcinoma AJCC v8, Stage IV Small Intestinal Adenocarcinoma AJCC v8
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants are randomly placed into one of two groups. In the first group, patients receive ramucirumab and paclitaxel through an IV. In the second group, patients receive a combination of irinotecan, leucovorin, and fluorouracil, also given through an IV. Both treatments are given in cycles, repeating every 28 days unless there are issues with the disease or side effects.
Where
This trial is running at 536 locations in the United States. 399 of them are currently recruiting.
Abbott-Northwestern Hospital
Minneapolis, Minnesota
Alaska Breast Care and Surgery LLC
Anchorage, Alaska
Alaska Oncology and Hematology LLC
Anchorage, Alaska
Alaska Women's Cancer Care
Anchorage, Alaska
Allegiance Health
Jackson, Michigan
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada
Anchorage Associates in Radiation Medicine
Anchorage, Alaska
Ann M Wierman MD LTD
Las Vegas, Nevada
The first 8 of 536 sites are listed here. The registry record has the full list.