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
  Purpose

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

Condition Intervention Phase
Carcinoma, Hepatocellular
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST [ Time Frame: During the Study Conduct ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Study Start Date: July 2004
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
  Eligibility

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

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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00280618

Sponsors and Collaborators
Sanofi
Investigators
Study Director: Pingkuan Zhang Sanofi
  More Information

No publications provided

Responsible Party: Medical Affairs Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00280618     History of Changes
Other Study ID Numbers: L_9202
Study First Received: January 20, 2006
Last Updated: September 14, 2009
Health Authority: China: 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
Oxaliplatin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014