Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma

Primary objective:

To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

Secondary objective:

To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

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 lesion.

• 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 Limit(UNL)
  • Total Bilirubin ≤ 1.5 x UNL
  • International Normalized Ratio < 1.5
  • Child stage A or B
  • Creatinine ≤ 1.5 X UNL

Exclusion Criteria:

• 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 contraceptive methods.
• 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.