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

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00559455
First received: November 15, 2007
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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 Intervention Phase
Carcinoma, Hepatocellular
Drug: Oxaliplatin
Drug: Fluorouracil
Drug: Leucovorin
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Progression (TTP), 6 month survival, overall survival, AFP [ Time Frame: from the signature of Informed Consent up to end of the study ] [ Designated as safety issue: No ]

Enrollment: 38
Study Start Date: September 2007
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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

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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00559455

Locations
Korea, Republic of
Sanofi-Aventis Administrative Office
Seoul, Korea, Republic of
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Hyang Rim Kim Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, Sanofi-aventis Korea
ClinicalTrials.gov Identifier: NCT00559455     History of Changes
Other Study ID Numbers: OXALI_L_02859
Study First Received: November 15, 2007
Last Updated: June 27, 2011
Health Authority: Korea: 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
Fluorouracil
Oxaliplatin
Leucovorin
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents

ClinicalTrials.gov processed this record on April 17, 2014