drugset / Trial / NCT00200200

Hepatic Arterial Infusion With Floxuridine and Dexamethasone Combination With Chemotherapy With/Without Bevacizumab for Hepatic Metastases From Colorectal Cancer

NCT00200200 ↗

Phase 2 Completed 73 enrolled Memorial Sloan Kettering Cancer Center
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to determine whether the addition of bevacizumab, to hepatic arterial therapy with floxuridine (FUDR) and dexamethasone (Dex) (regional chemotherapy), and either oxaliplatin or CPT-11, plus 5-fluorouracil and leucovorin (systemic chemotherapy) will increase disease free survival in patients who have undergone liver resection. The patient will be randomized (a computer generated decision as in the flip of a coin) to receive, or not to receive bevacizumab in addition to regional and systemic chemotherapy.

Timeline

Start
2004-11-19
Primary completion
2025-03-13
Completion
2025-03-13

Drugs

EvaluationDrugModalityDoseRoute
Comparator Bevacizumab Monoclonal antibody — —
Subject Irinotecan Small molecule — Intravenous
Comparator Oxaliplatin Small molecule — Intravenous
Background Leucovorin Small molecule — Intravenous
Background fluorouracil Small molecule — —