Oxaliplatin in Unresectable Hepatocellular Carcinoma

NCT ID: NCT00280618

Last Updated: 2009-09-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-07-31

Brief Summary

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

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Oxaliplatin

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

sanofi-aventis

Principal Investigators

Pingkuan Zhang

Role: STUDY_DIRECTOR

Sanofi

Other Identifiers

L_9202

Identifier Type: -

Identifier Source: org_study_id