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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Colorectal Cancer
Metastasis
Liver Cancer
 Drug: Oxaliplatin (via HAI)
Drug: 5 Fluorouracil (systemic)
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Hepatic Arterial Infusion of Oxaliplatin Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical College of Wisconsin:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • toxicity
  • HAI complexity
  • cost

Estimated Enrollment: 15
Study Start Date: October 2005
Estimated Study Completion Date: December 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00244348

Contacts
Contact: Robert K Ausman, M. D. 847 438 3388 rausman.mildon@comcast.net

Locations
United States, Wisconsin
Medical College of Wisconsin/ Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Principal Investigator: Robert K Ausman, M. D.            
Sponsors and Collaborators
Medical College of Wisconsin
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00244348     History of Changes
Other Study ID Numbers: HRRC#341-05
Study First Received: October 25, 2005
Last Updated: October 11, 2006
Health Authority: United States: Institutional Review Board

Keywords provided by Medical College of Wisconsin:
hepatic artery infusion
colorectal cancer
liver metastasis
oxaliplatin
5 fluorouracil

Additional relevant MeSH terms:
Colorectal Neoplasms
Liver Neoplasms
Neoplasm Metastasis
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Liver Diseases
 Neoplastic Processes
Pathologic Processes
Fluorouracil
Oxaliplatin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013