Oxaliplatin in Unresectable Hepatocellular Carcinoma

Sanofi

Status and phase

Completed

Phase 2

Conditions

Carcinoma, Hepatocellular

Treatments

Drug: Oxaliplatin

Study type

Interventional

Funder types

Industry

Identifiers

L_9202

Details and patient eligibility

About

Primary:

To determine the Tumor Response Rate of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-Fluorouracil/Leucovorin

Secondary:

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.