Colon Cancer Clinical Trial
Hepatic Arterial Infusion With Floxuridine and Systemic Irinotecan After Surgery in Treating Patients With Hepatic (Liver) Metastases From Colorectal Cancer
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.
Full 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 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
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There are 10 Locations for this study
Little Rock Arkansas, 72205, United States
Lexington Kentucky, 40503, United States
Boston Massachusetts, 02114, United States
Minneapolis Minnesota, 55455, United States
Buffalo New York, 14263, United States
New York New York, 10021, United States
Chapel Hill North Carolina, 27599, United States
Winston-Salem North Carolina, 27157, United States
Oklahoma City Oklahoma, 73112, United States
Providence Rhode Island, 02908, United States
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