NCT00200200

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

Completed Phase 2 Last updated 19 March 2025

What this trial tests

Phase 2 trial testing Bevacizumab HAI plus systemic chemotherapy in Hepatic Metastases in 73 participants. Completed in 13 March 2025.

Timeline

19 November 2004

Primary endpoint
13 March 2025

13 March 2025

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	73
Start date	19 November 2004
Primary completion	13 March 2025
Estimated completion	13 March 2025
Sites	5 locations across United States

Drugs / interventions tested

• Bevacizumab HAI plus systemic chemotherapy — full drug profile →
• HAI plus systemic chemotherapy — full drug profile →

Conditions studied

• Hepatic Metastases — all drugs for Hepatic Metastases →
• Colon Cancer — all drugs for Colon Cancer →
• Rectal Cancer — all drugs for Rectal Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

19 and older, any sex, with Hepatic Metastases or Colon Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. Metabolism, Biochemical Actions, and Chemical Synthesis of Anticancer Nucleosides, Nucleotides, and Base Analogs.
   Shelton J, Lu X, Hollenbaugh JA, Cho JH, et al · · 2016 · cited 219× · PMID 27960273 · DOI 10.1021/acs.chemrev.6b00209
2. Randomized phase II trial of adjuvant hepatic arterial infusion and systemic chemotherapy with or without bevacizumab in patients with resected hepatic metastases from colorectal cancer.
   Kemeny NE, Jarnagin WR, Capanu M, Fong Y, et al · · 2011 · cited 81× · PMID 21189384 · DOI 10.1200/jco.2010.32.5977
3. Anti-angiogenic therapies for metastatic colorectal cancer.
   Wagner AD, Arnold D, Grothey AA, Haerting J, et al · · 2009 · cited 66× · PMID 19588372 · DOI 10.1002/14651858.cd005392.pub3
4. Potential lymphangiogenesis therapies: Learning from current antiangiogenesis therapies-A review.
   Yamakawa M, Doh SJ, Santosa SM, Montana M, et al · · 2018 · cited 42× · PMID 29528507 · DOI 10.1002/med.21496
5. Accomplishments in 2008 in the management of curable metastatic colorectal cancer.
   Adam R, Hoti E, Folprecht G, Benson AB. · · 2009 · cited 19× · PMID 20011559
6. Hepatic Artery Infusion Chemotherapy for Primary and Secondary Malignancies of the Liver: State of the Art and Current High-Level Evidence.
   Kuemmerli C, Hess V, Dutkowski P, Sinz S, et al · · 2024 · cited 3× · PMID 38368862 · DOI 10.1159/000537887