Status:
WITHDRAWN
Hepatic Artery Infusion With Oxaliplatin
Lead Sponsor:
Medical College of Wisconsin
Conditions:
Colorectal Cancer
Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
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 i...
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 infus...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Concomitant anticancer therapy other than this protocol
- Gastroduodenal ulcer
- Pregnancy or lactation
- Last treatment for colon cancer less than 4 weeks from this protocol
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00244348
Start Date
October 1 2005
End Date
August 1 2015
Last Update
August 27 2015
Active Locations (1)
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1
Medical College of Wisconsin/ Froedtert Hospital
Milwaukee, Wisconsin, United States, 53226