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

NCT ID: NCT00471965

Last Updated: 2010-09-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 371 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-03-31
• Study Completion Date: 2010-03-31

Brief Summary

Primary:

• Overall Survival (OS)

Secondary:

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

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

A

Oxaliplatin + 5-Fluorouracil/Leucovorin

Group Type: EXPERIMENTAL

Oxaliplatin + 5-Fluorouracil/Leucovorin

Intervention Type: DRUG

Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.

Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.

Repeated every 2 weeks

B

Doxorubicin

Group Type: ACTIVE_COMPARATOR

Doxorubicin

Intervention Type: DRUG

Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.

Interventions

Oxaliplatin + 5-Fluorouracil/Leucovorin

Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion.

Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion.

Repeated every 2 weeks

Intervention Type: DRUG

Doxorubicin

Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi-aventis

Principal Investigators

Benedict Blayney

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Shanghai, , China

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Sanofi-Aventis Administrative Office

Taipei, , Taiwan

Sanofi-Aventis Administrative Office

Bangkok, , Thailand

Countries

China; South Korea; Taiwan; Thailand

References

Qin S, Cheng Y, Liang J, Shen L, Bai Y, Li J, Fan J, Liang L, Zhang Y, Wu G, Rau KM, Yang TS, Jian Z, Liang H, Sun Y. Efficacy and safety of the FOLFOX4 regimen versus doxorubicin in Chinese patients with advanced hepatocellular carcinoma: a subgroup analysis of the EACH study. Oncologist. 2014 Nov;19(11):1169-78. doi: 10.1634/theoncologist.2014-0190. Epub 2014 Sep 15.

Reference Type: DERIVED

PMID: 25223462 (View on PubMed)

Other Identifiers

OXALI_L_00858

Identifier Type: -

Identifier Source: org_study_id