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

NCT00471965 | Completed Phase 3

• 1 other identifier: OXALI_L_00858
• Study Type: interventional
• Target: 371
• Locations: 4 countries
• Sites: 4

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

Outcome Measures

Primary Outcomes (1)

• Overall survival

  From the date of randomization to the date of death due to any cause

Secondary Outcomes (2)

• Time to progression

  From the date of randomization to documentation of progression

• Response rate, secondary resection rate, quality of life

  From the date of randomization to the end of study

Study Arms (2)

A

EXPERIMENTAL

Oxaliplatin + 5-Fluorouracil/Leucovorin

Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin

B

ACTIVE COMPARATOR

Doxorubicin

Drug: Doxorubicin

Interventions

Oxaliplatin + 5-Fluorouracil/Leucovorin 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

A

Doxorubicin DRUG

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

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (4)

Sanofi-Aventis Administrative Office

Shanghai, China

Location

Sanofi-Aventis Administrative Office

Seoul, South Korea

Location

Sanofi-Aventis Administrative Office

Taipei, Taiwan

Location

Sanofi-Aventis Administrative Office

Bangkok, Thailand

Location

Related Publications (1)

• 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.

  PMID: 25223462 DERIVED

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin; Fluorouracil; Leucovorin; Doxorubicin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals; Uracil; Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Formyltetrahydrofolates; Tetrahydrofolates; Folic Acid; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Coenzymes; Enzymes and Coenzymes; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates

Study Officials

• Benedict Blayney

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: May 9, 2007
• First Posted: May 10, 2007
• Study Start: March 1, 2007
• Primary Completion: March 1, 2010
• Study Completion: March 1, 2010
• Last Updated: September 20, 2010

Record last verified: 2010-09

Locations

KR (1); TW (1); CN (1); TH (1)