NCT00492999

A Phase II Study of the Rate of Conversion to Complete Resection in Patients With Initially Inoperable Hepatic-Only Metastases From Colorectal Cancer After Treatment With Hepatic Arterial Infusion With Floxuridine and Dexamethasone in Combination With Best Systemic Chemotherapy

Active, enrolled Phase 2 Last updated 1 June 2026

What this trial tests

Phase 2 trial testing dexamethasone in Colorectal Cancer in 64 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 May 2007

Primary endpoint
1 May 2027

1 May 2027

Quick facts

Lead sponsor	Memorial Sloan Kettering Cancer Center
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	64
Start date	1 May 2007
Primary completion	1 May 2027
Estimated completion	1 May 2027
Sites	5 locations across United States

Drugs / interventions tested

• dexamethasone (dexamethasone) — full drug profile →
• floxuridine (FLOXURIDINE) — full drug profile →
• fluorouracil — full drug profile →
• irinotecan hydrochloride
• leucovorin calcium
• oxaliplatin (Oxaliplatin) — full drug profile →

Conditions studied

• Colorectal Cancer — all drugs for Colorectal Cancer →
• Metastatic Cancer — all drugs for Metastatic Cancer →

Sponsor

Memorial Sloan Kettering Cancer Center — full company profile →

Who can join

Adults 18 to 120, any sex, with Colorectal Cancer or Metastatic Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Resectability rate
  Time frame: 2 years

Sponsor's own description

RATIONALE: Hepatic arterial infusion uses a catheter to carry tumor-killing substances directly into the liver. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving floxuridine and dexamethasone directly into the arteries around the tumor together with combination chemotherapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well hepatic arterial infusion with floxuridine and dexamethasone works when given together with combination chemotherapy in treating patients with colorectal cancer that has spread to the liver.

Publications & conference data

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

1. Phase II trial of hepatic artery infusional and systemic chemotherapy for patients with unresectable hepatic metastases from colorectal cancer: conversion to resection and long-term outcomes.
   DʼAngelica MI, Correa-Gallego C, Paty PB, Cercek A, et al · · 2015 · cited 146× · PMID 24646562 · DOI 10.1097/sla.0000000000000614
2. Prospective phase II trial of combination hepatic artery infusion and systemic chemotherapy for unresectable colorectal liver metastases: Long term results and curative potential.
   Pak LM, Kemeny NE, Capanu M, Chou JF, et al · · 2018 · cited 85× · PMID 29165816 · DOI 10.1002/jso.24898
3. Accomplishments in 2008 in the management of curable metastatic colorectal cancer.
   Adam R, Hoti E, Folprecht G, Benson AB. · · 2009 · cited 19× · PMID 20011559
4. Anatomical Targeting of Anticancer Drugs to Solid Tumors Using Specific Administration Routes: Review.
   Saito A, Kitayama J, Nagai R, Aizawa K. · · 2023 · cited 11× · PMID 37376112 · DOI 10.3390/pharmaceutics15061664
5. Perioperative Systemic Chemotherapy for Colorectal Liver Metastasis: Recent Updates.
   Lee HY, Woo IS. · · 2021 · cited 6× · PMID 34572817 · DOI 10.3390/cancers13184590
6. Prospective evaluation of 18F-fluorodeoxyglucose positron emission tomography in patients receiving hepatic arterial and systemic chemotherapy for unresectable colorectal liver metastases.
   Correa-Gallego C, Gavane S, Grewal R, Cercek A, et al · · 2015 · cited 5× · PMID 26010778 · DOI 10.1111/hpb.12421