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

Sanofi

Status and phase

Completed

Phase 3

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin

Drug: Doxorubicin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00471965

OXALI_L_00858

Details and patient eligibility

About

Primary:

Overall Survival (OS)

Secondary:

Time to Tumor Progression (TTP)
Response Rate (RR)
Improvement of Quality of Life (QoL)
Safety
Secondary resection rate

Enrollment

371 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.