Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients

• Status: Completed
• Trial end date: 2010-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Primary:

• Overall Survival (OS)

Secondary:

• Time to Tumor Progression (TTP)

• Response Rate (RR)

• Improvement of Quality of Life (QoL)

• Safety

• Secondary resection rate

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Doxorubicin; Fluorouracil; Leucovorin; Liposomal doxorubicin; Oxaliplatin

Criteria

Inclusion Criteria:

• Histologically, cytologically or clinically diagnosed (in patient with cirrhosis, Alpha-Fetoprotein(AFP)≥400μg/L and morphological evidence [contrast Computed Tomography(CT)/Magnetic Resonance Imaging(MRI)] of hypervascular liver tumor, elevated AFP level due to other reasons [germ cell carcinoma, progressive chronic hepatitis, pregnancy, etc] can be excluded) unresectable hepatocellular carcinoma, ineligible or if the patient does not consent to receive local invasive treatment (chemo-embolism, ablation, etc.).

• At least one measurable lesion (on CT: ≥2cm, on spiral CT or MRI ≥1cm)

• Have not received previous palliative systemic chemotherapy for metastatic disease. If the patient received previous systemic chemotherapy as adjuvant treatment, he must have been completed at least 12 months previously.

• 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 8 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.

• Karnofsky Performance Score≥70, Barcelona of Cancer Liver Category stage B/C

• Patients must have adequate organ and marrow function:

• Neutrophilus≥1.5X10^9/L

• Platelets≥75X10^9/L

• Asparagine AminoTransferase,Alanine AminoTransferase<2.5 Upper Normal Limit(UNL)

• Total Bilirubin<1.5 UNL

• International Normalized Ratio<1.5

• Child stage A or B

• Normal base line Left Ventricular Ejection Fraction (LVEF result must be above or equal to the lower limit of normal for the institution)

Exclusion Criteria:

• Documented allergy to platinum compound or to other study drugs.

• Any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization.

• Previous liver transplantation.

• Patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as "anti-cancer" medicine, except radiotherapy to non-target lesion (bone metastasis, etc)

• 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.