Hepatic Artery Infusion With Oxaliplatin

Colorectal Cancer Clinical Trial

Official title:

Hepatic Arterial Infusion of Oxaliplatin Clinical Trial

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00244348
• Other study ID #: HRRC#341-05
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• First received: October 25, 2005
• Last updated: August 26, 2015
• Start date: October 2005
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Medical College of Wisconsin
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms
• Liver Cancer
• Metastasis

Intervention

Drug:
• Oxaliplatin (via HAI)

• 5 Fluorouracil (systemic)

Locations

Country	Name	City	State
United States	Medical College of Wisconsin/ Froedtert Hospital	Milwaukee	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
Medical College of Wisconsin

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of patients who become eligible for total resection of metastatic liver tumor
Primary	overall survival of patients resected for cure versus (vs.) resected for palliation vs. not resected.
Secondary	toxicity
Secondary	HAI complexity
Secondary	cost