Phase II Study Comparing Ramucirumab Plus Paclitaxel Versus FOLFIRI for Advanced or Refractory Small Bowel Adenocarcinoma

What this Trial Is About

Researchers are evaluating the effectiveness of ramucirumab combined with paclitaxel versus the FOLFIRI regimen leucovorin calcium, fluorouracil, and irinotecan hydrochloride in treating patients with advanced or treatment-resistant small bowel adenocarcinoma. Ramucirumab is a monoclonal antibody that targets VEGFR-2 to potentially reduce tumor blood supply and growth. Chemotherapy drugs like paclitaxel, leucovorin calcium, fluorouracil, and irinotecan work by stopping tumor cell growth through different mechanisms. Participants are randomly assigned to one of two treatment groups. In the first group, patients receive ramucirumab intravenously over 30-60 minutes on days 1 and 15, and paclitaxel intravenously over 30 minutes on days 1, 8, and 15, with each cycle lasting 28 days. In the second group, patients receive irinotecan intravenously over 90 minutes on days 1 and 15, leucovorin intravenously over 2 hours on days 1 and 15, and fluorouracil both as an IV bolus on days 1 and 15 and continuously over 46-48 hours on days 1-3 and 15-17. Treatment cycles repeat every 28 days unless disease progresses or side effects become unacceptable. During the study, patients are monitored with assessments every 8 weeks until their disease progresses. After progression, follow-up continues every 6 months for up to 3 years. Researchers measure progression-free survival, overall response rate, overall survival, and track any adverse events. Tissue and blood samples are also collected for future research. Patient safety and treatment effects are carefully evaluated throughout the study.

Ramucirumab and Paclitaxel or FOLFIRI in Advanced Small Bowel Cancers