Primary:

• To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

Secondary:

• Safety and tolerability of this regimen in these patients

Inclusion Criteria:

• Patients must have histologically confirmed hepatocellular carcinoma

• Patients must have measurable disease by CT scan

• Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.

• The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.

• WHO performance status: 0 to 2

• Patients must have adequate organ and marrow function as defined below:

  • Leukocytes : ≥ 3,000/μl
  • Absolute neutrophil count :≥ 1,500/μl
  • Platelets : ≥ 80,000/μl
  • Total bilirubin : < 3.0g/dl
  • ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
  • Creatinine : < 120μmol/l

• Patients with no evidence of clinically significant neuropathy.

Exclusion Criteria:

• Documented allergy to platinum compound or to others study's drugs

• Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)

• Hematological disorder or malignancies

• Metastasis to central nervous system

• Other serious illness or medical conditions:

  • Active infectious disease
  • Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.

• Concurrent treatment with any other anticancer therapy

• Concurrent treatment with other experimental drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.