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.

Study Overview

• Status: Withdrawn
• Conditions: Colorectal Cancer; Metastasis; Liver Cancer
• Intervention / Treatment: Drug: Oxaliplatin (via HAI); Drug: 5 Fluorouracil (systemic)

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 Type: Interventional
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin/ Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
toxicity
cost
HAI complexity

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2005
• Primary Completion (Anticipated): August 1, 2015
• Study Completion (Actual): August 1, 2015

Study Registration Dates

• First Submitted: October 25, 2005
• First Submitted That Met QC Criteria: October 25, 2005
• First Posted (Estimate): October 26, 2005

Study Record Updates

• Last Update Posted (Estimate): August 27, 2015
• Last Update Submitted That Met QC Criteria: August 26, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Keywords: colorectal cancer; oxaliplatin; liver metastasis; 5 fluorouracil; hepatic artery infusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplastic Processes; Colorectal Neoplasms; Neoplasm Metastasis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Fluorouracil; Oxaliplatin
• Other Study ID Numbers: HRRC#341-05