Spots Global Cancer Trial Database for Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
Official Title: 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
Study ID: NCT00063960
Study Description
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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
University of Minnesota Cancer Center, Minneapolis, Minnesota, United States
Roswell Park Cancer Institute, Buffalo, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill, Chapel Hill, North Carolina, United States
Comprehensive Cancer Center at Wake Forest University, Winston-Salem, North Carolina, United States
Integris Oncology Services, Oklahoma City, Oklahoma, United States
University Medical Group, Providence, Rhode Island, United States
Contact Details
Name: Yuman Fong, MD
Affiliation: Memorial Sloan Kettering Cancer Center
Role: STUDY_CHAIR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
