Hepatic Artery Infusion With Oxaliplatin

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2005-10-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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After entry qualification and registration patients will undergo hepatic artery catheterization via interventional radiology. The catheter will remain in place for two hours while oxaliplatin is infused and then be removed. This treatment will be followed by a 48 hour infusion of 5FU and leucovorin, generally following the principle of FOLFOX 6. These cycles of therapy will be repeated biweekly for six episodes. Hepatic tumor size will be evaluated by CT scan to determine if resectability has been established as the result of tumor size reduction. If so, the patient will be offered resection of the residual lesions in an effort to achieve long term survival.

Conditions

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Colorectal Cancer Metastasis Liver Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Oxaliplatin (via HAI)

Intervention Type DRUG

5 Fluorouracil (systemic)

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No