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Oxaliplatin + 5-FluoroUracil/LeucoVorin(5-FU/LV) (FOLFOX4) vs Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients (EACH)
This study is currently recruiting participants.
Verified by Sanofi-Aventis, December 2008
First Received: May 9, 2007   Last Updated: December 22, 2008   History of Changes
Sponsored by: Sanofi-Aventis
Information provided by: Sanofi-Aventis
ClinicalTrials.gov Identifier: NCT00471965
  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 III

Drug Information available for: Fluorouracil Leucovorin Doxorubicin Doxorubicin hydrochloride Citrovorum factor Oxaliplatin Myocet Leucovorin Calcium Folinic acid calcium salt pentahydrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
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

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:
  • Overall survival [ Time Frame: From randomization to primary endpoint ] [ Designated as safety issue: No ]

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

Estimated Enrollment: 440
Study Start Date: March 2007
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
A: Experimental
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

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

Contacts
Contact: Public Registry GMA PublicRegistryGMA@sanofi-aventis.com

Locations
China
Sanofi-Aventis Recruiting
Shanghai, China
Korea, Republic of
Sanofi-Aventis Active, not recruiting
Seoul, Korea, Republic of
Taiwan
Sanofi-Aventis Recruiting
Taipei, Taiwan
Thailand
Sanofi-Aventis Recruiting
Bangkok, Thailand
Sponsors and Collaborators
Sanofi-Aventis
Investigators
Study Director: Benedict Blayney Sanofi-Aventis
  More Information

No publications provided

Responsible Party: Sanofi-aventis ( Medical Affairs Study Director )
Study ID Numbers: OXALI_L_00858
Study First Received: May 9, 2007
Last Updated: December 22, 2008
ClinicalTrials.gov Identifier: NCT00471965     History of Changes
Health Authority: China: State Food and Drug Administration

Study placed in the following topic categories:
Antimetabolites
Liver Diseases
Vitamin B Complex
Digestive System Neoplasms
Immunologic Factors
Carcinoma, Hepatocellular
Leucovorin
Trace Elements
Immunosuppressive Agents
Doxorubicin
Carcinoma
Liver Neoplasms
Anti-Bacterial Agents
Oxaliplatin
Digestive System Diseases
Vitamins
Fluorouracil
Gastrointestinal Neoplasms
Micronutrients
Adenocarcinoma
Hepatocellular Carcinoma
Neoplasms, Glandular and Epithelial

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

ClinicalTrials.gov processed this record on May 07, 2009