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Hepatic Artery Infusion With Oxaliplatin

Hepatic Arterial Infusion of Oxaliplatin Clinical Trial

Status
Withdrawn
Phases
Phase 1Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00244348
Enrollment
0
Registered
2005-10-26
Start date
2005-10-31
Completion date
2015-08-31
Last updated
2015-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Cancer, Liver Cancer, Metastasis

Keywords

hepatic artery infusion, colorectal cancer, liver metastasis, oxaliplatin, 5 fluorouracil

Brief 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.

Detailed description

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.

Interventions

DRUGOxaliplatin (via HAI)
DRUG5 Fluorouracil (systemic)

Sponsors

Medical College of Wisconsin
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
number of patients who become eligible for total resection of metastatic liver tumor
overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.

Secondary

MeasureTime frame
toxicity
HAI complexity
cost

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026