Hepatic Artery Infusion With Oxaliplatin
| Status: | Withdrawn |
|---|---|
| Conditions: | Colorectal Cancer, Liver Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | October 2005 |
| End Date: | August 2015 |
Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
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.
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.
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.
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.
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
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