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Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00559455
Recruitment Status : Completed
First Posted : November 16, 2007
Last Update Posted : June 28, 2011
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Brief Summary:

Primary objective:

To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

Secondary objective:

To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

Condition or disease Intervention/treatment Phase
Carcinoma, Hepatocellular Drug: Oxaliplatin Drug: Fluorouracil Drug: Leucovorin Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 38 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
Study Start Date : September 2007
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: Oxaliplatin
85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks

Drug: Fluorouracil
400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks

Drug: Leucovorin
200mg/m², Day 1 and Day 2; Every 2 weeks

Primary Outcome Measures :
  1. Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan [ Time Frame: every 6 weeks ]

Secondary Outcome Measures :
  1. Time to Progression (TTP), 6 month survival, overall survival, AFP [ Time Frame: from the signature of Informed Consent up to end of the study ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Lists of Inclusion and Exclusion criteria:

  • Patients must have histologically confirmed hepatocellular carcinoma
  • Patients must have measurable disease by CT scan
  • Have not received previous palliative systemic chemotherapy for metastatic disease. (Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)
  • 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 4 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
  • WHO 0-2 grades (Karnofsky Performance Score ≥ 70)
  • Patients must have adequate organ and marrow function:

    • Neutrophilus ≥ 1.5 x 10^9/L
    • Platelets ≥ 75 x 10^9/L
    • Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal Limit(UNL)
    • Total Bilirubin ≤ 1.5 x UNL
    • International Normalized Ratio < 1.5
    • Child stage A or B
    • Creatinine ≤ 1.5 X UNL

Exclusion Criteria:

  • Documented allergy to platinum compound or to other study drugs.
  • Active Gastro-Intestinal bleeding and active haematologic malignancy
  • Previous liver transplantation.
  • Patients concomitantly receiving any other anti-cancer therapy.
  • 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
  • Neuropathy ≥ grade 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00559455

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Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
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Study Director: Hyang Rim Kim Sanofi
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Responsible Party: Medical Affairs Study Director, Sanofi-aventis Korea Identifier: NCT00559455    
Other Study ID Numbers: OXALI_L_02859
First Posted: November 16, 2007    Key Record Dates
Last Update Posted: June 28, 2011
Last Verified: June 2011
Additional relevant MeSH terms:
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Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex