A Phase II Trial Of Toxicity Assessment In Two Cohorts Of Patients (Resection Alone Or Ablation With Or Without Resection Of Hepatic Metastases From Colorectal Cancer) Treated With Adjuvant Hepatic Arterial Infusion (HAI) FUDR Plus Systemic CPT-11
- 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
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
Patients are followed every 3 months for 2 years.
PROJECTED ACCRUAL: A total of 28-94 patients (14-47 patients per stratum) will be accrued
for this study within 2 years.
Masking: Open Label, Primary Purpose: Treatment
Yuman Fong, MD
Memorial Sloan-Kettering Cancer Center
United States: Federal Government
|Roswell Park Cancer Institute||Buffalo, New York 14263|
|Memorial Sloan-Kettering Cancer Center||New York, New York 10021|
|University of Minnesota Cancer Center||Minneapolis, Minnesota 55455|
|Massachusetts General Hospital Cancer Center||Boston, Massachusetts 02114|
|Comprehensive Cancer Center at Wake Forest University||Winston-Salem, North Carolina 27157-1082|
|Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill||Chapel Hill, North Carolina 27599-7570|
|Arkansas Cancer Research Center at University of Arkansas for Medical Sciences||Little Rock, Arkansas 72205|
|Central Baptist Hospital||Lexington, Kentucky 40503|
|Integris Oncology Services||Oklahoma City, Oklahoma 73112|
|University Medical Group||Providence, Rhode Island 02908-4735|