Hepatic Artery Infusion With Oxaliplatin

• Status: Withdrawn
• Trial end date: 2015-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Medical College of Wisconsin
• Treatments: Fluorouracil; Oxaliplatin

Criteria

Inclusion Criteria:

1. Signed consent

2. Age greater than 17 years

3. Stage IV colorectal cancer

4. Metastasis limited to the liver considered unresectable for cure by standard methods

5. Completely resected primary tumor

6. Life expectancy greater than 3 years excluding cancer

7. Eastern Cooperative Oncology Group (ECOG) status 0, 1, 2

8. Absolute granulocyte count greater than 1500

9. Platelet count greater than 100,000

10. Adequate hepatic function

11. Adequate renal function

Exclusion Criteria:

1. Concomitant anticancer therapy other than this protocol

2. Gastroduodenal ulcer

3. Pregnancy or lactation

4. Last treatment for colon cancer less than 4 weeks from this protocol