A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum (Per 04/99 Amendment) Old Title: A Phase II Study of Patients With Unresectable Metastatic Adenocarcinoma of the Colon or Rectum Confined to the Liver

Inclusion Criteria

DISEASE CHARACTERISTICS: History of carcinoma of the colon or rectum in which the primary
site has been completely resected Measurable or evaluable unresectable liver metastases
with one or more of the following: Involvement of all 3 major hepatic veins, the portal
vein bifurcation, or the retrohepatic vena cava Involvement of the main right or the main
left portal vein and the main hepatic vein of the opposite lobe Disease requiring more
than a right or left trisegmentectomy Six or more metastatic lesions distributed diffusely
in both lobes of the liver

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy:
Not specified Hematopoietic: WBC at least 3,500/mm3 Platelet count at least 100,000/mm3
Hepatic: Bilirubin normal SGOT no greater than 3 times upper limit of normal (ULN) No
chronic hepatic disease (e.g., chronic active hepatitis, cirrhosis) Renal: Creatinine no
greater than 1.5 times ULN Cardiovascular: No history of myocardial infarction within the
past 6 months No congestive heart failure Other: No other malignancy within the past 5
years except basal cell or squamous cell skin cancer or carcinoma in situ of any organ or
other tumor associated with less than 10% probability of death from malignant disease
within 5 years of diagnosis Adequate oral nutrition including estimated intake of at least
1,500 calories per day No severe anorexia or frequent nausea and/or vomiting Able to
withstand a major operative procedure No neuropathy Not pregnant or nursing Negative
pregnancy test Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent immunotherapy Concurrent
filgrastim or epoetin alfa allowed Chemotherapy: At least one year since prior adjuvant
systemic fluorouracil with or without levamisole or leucovorin No prior systemic or
hepatic artery infusion chemotherapy for metastatic disease No other concurrent
chemotherapy Endocrine therapy: Not specified Radiotherapy: No prior radiotherapy to the
liver At least one year since radiotherapy to greater than 25% of bone marrow No
concurrent radiotherapy Surgery: At least 21 days since abdominal exploration with or
without intestinal resection Other: Oral cryotherapy allowed only on day 2 of each course