Carcinoma, Hepatocellular
Conditions
Brief summary
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
Interventions
DRUGOxaliplatin
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST | During the Study Conduct |
Secondary
| Measure | Time frame |
|---|---|
| Adverse Events collections and evaluation | From the signature of the informed consent up to the end of the study |
Outcome results
None listed