Hepatic Artery Infusion With Oxaliplatin

Withdrawn before enrolling · Phase 1/Phase 2

Conditions studied: Colorectal Cancer, Metastasis, Liver Cancer

In brief

Hepatic artery infusion (HAI) with oxaliplatin (OX), systemic 5 fluorouracil (5FU), and leucovorin (HAI/OX/FU) will be implemented using an interventional radiology technique to obviate the need for initial major surgery (catheter placement) in patients who have unresectable liver metastasis from colorectal cancer. The study goal is to reduce tumor size to make possible a complete resection of all lesions. Secondary goals are to reduce or eliminate the complexity usually associated with HAI, to accomplish most or all of the treatment as an outpatient, to reduce costs, and to avoid the hepatotoxicity associated with HAI/floxuridine (FUDR). Oxaliplatin has been selected because of its ease of use, known toxicology, and established efficacy in colorectal cancer.

Key facts

Study ID

NCT00244348

Run by

Medical College of Wisconsin

People needed

0

Starts

2005-10-01

Expected to finish

2015-08-01

Last updated by the study team

2015-08-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed consent
• Age greater than 17 years
• Stage IV colorectal cancer
• Metastasis limited to the liver considered unresectable for cure by standard methods
• Completely resected primary tumor
• Life expectancy greater than 3 years excluding cancer
• Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2
• Absolute granulocyte count greater than 1500
• Platelet count greater than 100,000
• Adequate hepatic function
• Adequate renal function

You may not qualify if…

• Concomitant anticancer therapy other than this protocol
• Gastroduodenal ulcer
• Pregnancy or lactation
• Last treatment for colon cancer less than 4 weeks from this protocol

Where it is running

• Medical College of Wisconsin/ Froedtert Hospital — Milwaukee, Wisconsin, United States

Full record on ClinicalTrials.gov

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