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

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 ]
Not Provided
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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
Not Provided
Not Provided

*   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