Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer

Phase 2

Completed

Brief Summary: RATIONALE: Drugs used in chemotherapy such as floxuridine and irinotecan use different ways to stop tumor cells from dividing so they stop growing or die. Hepatic arterial infusion uses a catheter to deliver chemotherapy directly to the liver. Combining more than one drug and giving them in different ways may kill any tumor cells remaining after surgery.

PURPOSE: Phase II trial to study the effectiveness of systemic irinotecan and hepatic arterial infusion with floxuridine after surgery in treating patients who have hepatic (liver) metastases from colorectal cancer.

Detailed Description: OBJECTIVES:

* Determine the toxicity of hepatic arterial infusion with floxuridine and systemic irinotecan adjuvant to liver metastases resection or ablation with or without resection in patients with hepatic metastases secondary to colorectal cancer.

* Determine the overall survival of patients treated with this regimen.

* Determine the time to any hepatic recurrence or progression in patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients are stratified according to prior therapy (liver metastases resection only vs ablation with or without resection).

Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity.

Patients are followed every 3 months for 2 years.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
floxuridine + irinotecan	floxuridine	Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.
floxuridine + irinotecan	irinotecan hydrochloride	Within 4-8 weeks after prior resection or ablation, patients receive hepatic arterial infusion of floxuridine continuously on days 1-14 and irinotecan IV over 30 minutes on days 1 and 15. Treatment repeats every 28 days for 6 courses in the absence of unacceptable toxicity. Patients are followed every 3 months for 2 years.

Primary Outcome Measures

Name	Time	Method
overall survival	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
time to hepatic recurrence or progression	Up to 2 years

Locations (10): Roswell Park Cancer Institute
🇺🇸
Buffalo, New York, United States
University Medical Group
🇺🇸
Providence, Rhode Island, United States
University of Minnesota Cancer Center
🇺🇸
Minneapolis, Minnesota, United States
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
🇺🇸
Little Rock, Arkansas, United States
Central Baptist Hospital
🇺🇸
Lexington, Kentucky, United States
Massachusetts General Hospital Cancer Center
🇺🇸
Boston, Massachusetts, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
🇺🇸
Chapel Hill, North Carolina, United States
Integris Oncology Services
🇺🇸
Oklahoma City, Oklahoma, United States
Comprehensive Cancer Center at Wake Forest University
🇺🇸
Winston-Salem, North Carolina, United States
Memorial Sloan-Kettering Cancer Center
🇺🇸
New York, New York, United States