Oxaliplatin in Unresectable Hepatocellular Carcinoma

NCT00280618 | Completed Phase 2

• 1 other identifier: L_9202
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• Time to Tumor Progression (TTP) and Response Rate: evaluated by RECIST

  During the Study Conduct

Secondary Outcomes (1)

• Adverse Events collections and evaluation

  From the signature of the informed consent up to the end of the study

Interventions

Oxaliplatin DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Oxaliplatin

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Coordination Complexes; Organic Chemicals

Study Officials

• Pingkuan Zhang

  Sanofi

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: January 20, 2006
• First Posted: January 23, 2006
• Study Start: July 1, 2004
• Primary Completion: November 1, 2006
• Last Updated: September 15, 2009

Record last verified: 2009-09