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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Fluorouracil; Leucovorin; Oxaliplatin

Criteria

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.