Ignite Creation Date:
2024-05-05 @ 12:07 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00244348
Status:
WITHDRAWN
Last Update Posted:
2015-08-27
First Post:
2005-10-25
Brief Title:
Hepatic Artery Infusion With Oxaliplatin
Sponsor:
Medical College of Wisconsin
Organization:
Medical College of Wisconsin
Study Overview
Official Title:
Hepatic Arterial Infusion of Oxaliplatin Clinical Trial
Status:
WITHDRAWN
Status Verified Date:
2015-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Investigator has left institution
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Hepatic artery infusion HAI with oxaliplatin OX systemic 5 fluorouracil 5FU and leucovorin HAIOXFU 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 HAIfloxuridine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None