Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma
- 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.
- Documented allergy to platinum compound or to others study's drugs
- Pregnant or lactating women or women of childbearing potential (e.g. not using
- 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
- 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.