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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00471965
First received: May 9, 2007
Last updated: September 17, 2010
Last verified: September 2010
  Purpose

Primary:

  • Overall Survival (OS)

Secondary:

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

Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin
Drug: Doxorubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From the date of randomization to the date of death due to any cause ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to progression [ Time Frame: From the date of randomization to documentation of progression ] [ Designated as safety issue: No ]
  • Response rate, secondary resection rate, quality of life [ Time Frame: From the date of randomization to the end of study ] [ Designated as safety issue: No ]

Enrollment: 371
Study Start Date: March 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Oxaliplatin + 5-Fluorouracil/Leucovorin
Drug: 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

Active Comparator: B
Doxorubicin
Drug: Doxorubicin
Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00471965

Locations
China
Sanofi-Aventis Administrative Office
Shanghai, China
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Taiwan
Sanofi-Aventis Administrative Office
Taipei, Taiwan
Thailand
Sanofi-Aventis Administrative Office
Bangkok, Thailand
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Benedict Blayney Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis
ClinicalTrials.gov Identifier: NCT00471965     History of Changes
Other Study ID Numbers: OXALI_L_00858
Study First Received: May 9, 2007
Last Updated: September 17, 2010
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Oxaliplatin
Fluorouracil
Leucovorin
Levoleucovorin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances

ClinicalTrials.gov processed this record on July 23, 2014