Oxaliplatin in Unresectable Hepatocellular Carcinoma

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular

• Registration Number: NCT00280618
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2004-07
• Study First Submitted: 2006-01-20
• Study First Submitted QC: 2006-01-20
• Study First Posted: 2006-01-23
• Primary Completion: 2006-11
• Status Verified: 2009-09
• Last Update Submitted: 2009-09-14
• Last Update Posted: 2009-09-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST	During the Study Conduct

Secondary Outcome Measures

Name	Time	Method
Adverse Events collections and evaluation	From the signature of the informed consent up to the end of the study