Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
Lists of Inclusion and Exclusion criteria:
- Patients must have histologically confirmed hepatocellular carcinoma
- Patients must have measurable disease by CT scan
- Have not received previous palliative systemic chemotherapy for metastatic disease.
(Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)
- Patients progress after previous local treatment and at the time of randomization is
at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion,
Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 4 weeks
after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target
- WHO 0-2 grades (Karnofsky Performance Score ≥ 70)
- Patients must have adequate organ and marrow function:
- Neutrophilus ≥ 1.5 x 10^9/L
- Platelets ≥ 75 x 10^9/L
- Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal
- Total Bilirubin ≤ 1.5 x UNL
- International Normalized Ratio < 1.5
- Child stage A or B
- Creatinine ≤ 1.5 X UNL
- Documented allergy to platinum compound or to other study drugs.
- Active Gastro-Intestinal bleeding and active haematologic malignancy
- Previous liver transplantation.
- Patients concomitantly receiving any other anti-cancer therapy.
- Patients who are receiving any other study treatments.
- Pregnant or lactating women or women of childbearing potential without proper
- History of other malignant diseases, except cured basal cell carcinoma of skin and
cured carcinoma in-situ of uterine cervix.
- Central nervous system metastasis
- Other serious illness or medical conditions
- Neuropathy ≥ grade 2
The above information is not intended to contain all considerations relevant to a
patient's potential participation in a clinical trial.