Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
Colorectal Cancer, Metastatic Cancer
About this trial
This is an interventional treatment trial for Colorectal Cancer focused on measuring stage IV colon cancer, adenocarcinoma of the colon, adenocarcinoma of the rectum, stage IV rectal cancer, liver metastases
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic colorectal adenocarcinoma Primary colorectal adenocarcinoma that has been completely resected (R0 disease) No evidence of residual, viable tumor by abdominal/pelvic helical CT scan or MRI with IV contrast Metastatic disease No more than 9 liver metastases All lesions completely resected or completely treated by ablation (with or without resection) All lesions treated by ablation must have been less than 5 cm in size and at least 5 mm away from main/left/right portal vein, common bile duct, and inferior vena cava All resected lesions must have a negative surgical margin (R0) Disease progression after prior systemic irinotecan for metastatic disease allowed No extrahepatic metastases confirmed by chest CT scan except colorectal mesenteric lymph node metastases resected at the time of primary tumor resection No other prior resection of extrahepatic metastases Must have the entire liver remnant perfused with a single catheter Must have a nuclear medicine macro-aggregated albumin flow scan to confirm the area of pump perfusion before study registration PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 OR Zubrod 0-2 Life expectancy Not specified Hematopoietic WBC at least 3,000/mm^3 Absolute granulocyte count at least 1,500/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic Bilirubin no greater than 2 mg/dL Alkaline phosphatase no greater than 2.0 times upper limit of normal (ULN) AST and ALT no greater than 2.0 times ULN No active hepatitis B or C infection No histological evidence of cirrhosis Renal Creatinine no greater than 1.5 times ULN Calcium less than 1.3 times ULN Other Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Postmenopausal women must be amenorrheic for at least 12 consecutive months to be deemed not fertile Medically fit to begin chemotherapy between 4 and 8 weeks after surgery Prior cancer allowed if all of the following criteria are met: Undergone potentially curative therapy for all prior malignancies No other malignancy within the past 5 years except the following: Effectively treated basal cell or squamous cell skin cancer Carcinoma in situ of the cervix that has been effectively treated by surgery alone Lobular carcinoma in situ of the ipsilateral or contralateral breast treated by surgery alone No evidence of recurrence of any prior malignancy No prior hepatic arterial infusion pump malfunction, malperfusion, or infection PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunologic or biologic therapy Chemotherapy No prior chemotherapy within 4 weeks before hepatic resection or hepatic ablation (with or without resection) No prior hepatic arterial infusion with fluorouracil or floxuridine Radiotherapy No concurrent adjuvant radiotherapy to the pelvis No other concurrent radiotherapy Other No other concurrent systemic therapy
Sites / Locations
- Arkansas Cancer Research Center at University of Arkansas for Medical Sciences
- Central Baptist Hospital
- Massachusetts General Hospital Cancer Center
- University of Minnesota Cancer Center
- Roswell Park Cancer Institute
- Memorial Sloan-Kettering Cancer Center
- Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
- Comprehensive Cancer Center at Wake Forest University
- Integris Oncology Services
- University Medical Group
Arms of the Study
Arm 1
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.