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

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

Endocrine therapy

• Not specified

Radiotherapy

• No concurrent adjuvant radiotherapy to the pelvis
• No other concurrent radiotherapy

Surgery

• See Disease Characteristics

Other

• No other concurrent systemic therapy