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Hepatic Artery Infusion With Oxaliplatin

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2005 by Medical College of Wisconsin.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Medical College of Wisconsin
ClinicalTrials.gov Identifier:
NCT00244348
First received: October 25, 2005
Last updated: October 11, 2006
Last verified: October 2005

October 25, 2005
October 11, 2006
October 2005
Not Provided
  • 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.
  • 1. # patients who become eligible for total resection of metastatic liver tumor
  • 2. overall survival of patients resected for cure vs. resected for palliation vs. not resected.
Complete list of historical versions of study NCT00244348 on ClinicalTrials.gov Archive Site
  • toxicity
  • HAI complexity
  • cost
  • 1. toxicity
  • 2. HAI complexity
  • 3. Cost
Not Provided
Not Provided
 
Hepatic Artery Infusion With Oxaliplatin
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Colorectal Cancer
  • Metastasis
  • Liver Cancer
  • Drug: Oxaliplatin (via HAI)
  • Drug: 5 Fluorouracil (systemic)
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
15
December 2007
Not Provided

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
Both
18 Years and older
No
Contact: Robert K Ausman, M. D. 847 438 3388 rausman.mildon@comcast.net
United States
 
NCT00244348
HRRC#341-05
Not Provided
Not Provided
Medical College of Wisconsin
Not Provided
Principal Investigator: Robert K Ausman, M. D. Dept. Surgery, Medical College of Wisconsin
Principal Investigator: Edward J Quebbeman, M. D. Dept. Surgery, Medical College of Wisconsin
Principal Investigator: William S Rilling, M. D. Dept. Radiology, Medical College of Wisconsin
Medical College of Wisconsin
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP