Status:
COMPLETED
Oxaliplatin in Unresectable Hepatocellular Carcinoma
Lead Sponsor:
Sanofi
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 tol...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00280618
Start Date
July 1 2004
Last Update
September 15 2009
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