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Oxaliplatin in Unresectable Hepatocellular Carcinoma

This study has been completed.
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00280618
First received: January 20, 2006
Last updated: September 14, 2009
Last verified: September 2009
History of Changes

January 20, 2006
September 14, 2009
July 2004
November 2006   (final data collection date for primary outcome measure)
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00280618 on ClinicalTrials.gov Archive Site
Adverse Events collections and evaluation [ Time Frame: From the signature of the informed consent up to the end of the study ] [ Designated as safety issue: No ]
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Oxaliplatin in Unresectable Hepatocellular Carcinoma
Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma

Primary:

  • To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

Secondary:

  • Safety and tolerability of this regimen in these patients
Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Carcinoma, Hepatocellular
Drug: Oxaliplatin
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2006   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients must have histologically confirmed hepatocellular carcinoma
  • Patients must have measurable disease by CT scan
  • Patients with unresectable, recurrent or metastatic disease may be chemonaive or may be previously treated by chemotherapy.
  • The period of washout of prior chemotherapy must be greater than 4 weeks from date of randomization. The prior chemotherapy should not include platinum compounds.
  • WHO performance status: 0 to 2

  • Patients must have adequate organ and marrow function as defined below:

    • Leukocytes : ≥ 3,000/μl
    • Absolute neutrophil count :≥ 1,500/μl
    • Platelets : ≥ 80,000/μl
    • Total bilirubin : < 3.0g/dl
    • ASAT/ALAT : ≤ 3 times the upper normal limits of the institute
    • Creatinine : < 120μmol/l
  • Patients with no evidence of clinically significant neuropathy.

Exclusion Criteria:

  • Documented allergy to platinum compound or to others study's drugs
  • Pregnant or lactating women or women of childbearing potential (e.g. not using adequate contraception)
  • Hematological disorder or malignancies
  • Metastasis to central nervous system

  • Other serious illness or medical conditions:

    • Active infectious disease
    • Congestive heart failure, or angina pectoris. Previous history of myocardial infarction within 1 year from study entry; uncontrolled hypertension or arrhythmia.
  • Concurrent treatment with any other anticancer therapy
  • Concurrent treatment with other experimental drugs.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00280618
L_9202
Not Provided
Medical Affairs Study Director, sanofi-aventis
Sanofi
Not Provided
Study Director: Pingkuan Zhang Sanofi
Sanofi
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP