Oxaliplatin in Unresectable Hepatocellular Carcinoma

Carcinoma, Hepatocellular Clinical Trial

Official title:

Phase II Study of Eloxatin + 5-Fluorouracil/Leucovorin in Patients With Unresectable Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00280618
• Other study ID #: L_9202
• Status: Completed
• Phase: Phase 2
• First received: January 20, 2006
• Last updated: September 14, 2009
• Start date: July 2004

Study information

• Verified date: September 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: November 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Oxaliplatin

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST		During the Study Conduct	No
Secondary	Adverse Events collections and evaluation		From the signature of the informed consent up to the end of the study	No