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

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Alliance for Clinical Trials in Oncology
Study ID
NCT00063960
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Aug 31, 2003
Status verified
Jul 2016
Primary completion
Dec 31, 2004
Completion
Dec 31, 2004

Study Design

Enrollment
94 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: floxuridine + irinotecan
    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 Measure

overall survival [ Time Frame: Up to 2 years ]

Locations (10)

FacilityCityStateZIPSite coordinators
Arkansas Cancer Research Center at University of Arkansas for Medical SciencesLittle RockArkansas72205-
Central Baptist HospitalLexingtonKentucky40503-9985-
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114-
University of Minnesota Cancer CenterMinneapolisMinnesota55455-
Roswell Park Cancer InstituteBuffaloNew York14263-0001-
Memorial Sloan-Kettering Cancer CenterNew YorkNew York10021-
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7213-
Comprehensive Cancer Center at Wake Forest UniversityWinston-SalemNorth Carolina27157-1082-
Integris Oncology ServicesOklahoma CityOklahoma73112-
University Medical GroupProvidenceRhode Island02908-4735-

Find similar trials in Little Rock, AR

By condition
Colorectal cancer
By specialty
OncologyGI oncology
By research site
Arkansas Cancer Research Center at University of Arkansas for Medical Sciences· Little Rock, ARCentral Baptist Hospital· Lexington, KYMassachusetts General Hospital Cancer Center· Boston, MAUniversity of Minnesota Cancer Center· Minneapolis, MNRoswell Park Cancer Institute· Buffalo, NYMemorial Sloan-Kettering Cancer Center· New York, NY

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