Nolatrexed Dihydrochloride Compared With Doxorubicin in Treating Patients With Recurrent or Unresectable Liver Cancer

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically or cytologically proven or presumptive diagnosis of hepatocellular carcinoma
• •* Presumptive diagnosis based on rising alpha-fetoprotein (AFP) levels over 2 assessments, CT scan or MRI of liver, spiral CT scan of portal/splenic vein, and biopsy evidence of cirrhosis
• •* Unresectable or recurrent disease after prior surgical resection or embolization therapy
• •Fibrolamellar histology allowed if considered surgically unresectable based on tumor size, extrahepatic involvement, or multiple lobe involvement
• •CLIP (Cancer of the Liver Italian Program) score less than 4
• •Concurrent assignment to a transplantation list allowed
• •PATIENT CHARACTERISTICS:
• •Age:
• •18 and over
• •Performance status:
• •Karnofsky 60-100%
• •Life expectancy:
• •Not specified
• •Hematopoietic:
• •Absolute neutrophil count at least 1,200/mm\^3
• •Platelet count at least 80,000/mm\^3
• •Hepatic:
• •Bilirubin no greater than 3.0 mg/dL (except for known Gilbert's Syndrome)
• •AST no greater than 5 times upper limit of normal (ULN)
• •PT no greater than 1.5 times ULN
• •Renal:
• •Creatinine no greater than 2.0 mg/dL
• •Cardiovascular:
• •No uncontrolled hypertension within the past 3 months
• •No unstable angina, symptomatic congestive heart failure, or myocardial infarction within the past 3 months
• •No uncontrolled cardiac arrhythmia
• •Other:
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No active bacterial infections
• •HIV negative
• •No AIDS
• •No other primary malignancy except carcinoma in situ of the cervix or urinary bladder or non-melanoma skin cancer
• •No mental incapacitation or psychiatric illness that would preclude study participation
• •No other severe disease that would preclude study participation
• •Candidate for placement of a central venous access device
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •Prior biologic therapy allowed
• •No concurrent biologic therapy
• •Chemotherapy:
• •No prior IV doxorubicin except intraarterial administration in locoregional therapy
• •Endocrine therapy:
• •Prior endocrine therapy allowed
• •No concurrent endocrine therapy
• •Radiotherapy:
• •Prior radiotherapy allowed
• •No concurrent radiotherapy
• •Surgery:
• •See Disease Characteristics
• •Surgery allowed if previously unresectable lesions become resectable
• •Recovered from any prior surgery
• •No concurrent liver transplantation
• •Other:
• •No other concurrent investigational or marketed anticancer drugs
• •No other concurrent therapy for hepatocellular carcinoma
• •No concurrent terfenadine, astemizole, or cisapride that may not be interrupted during nolatrexed dihydrochloride administration