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

Phase 2
18 Years
75 Years
Not Enrolling
Carcinoma, Hepatocellular

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

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

Outcome Measure:

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

Outcome Time Frame:

During the Study Conduct

Safety Issue:


Principal Investigator

Pingkuan Zhang

Investigator Role:

Study Director

Investigator Affiliation:



China: Food and Drug Administration

Study ID:




Start Date:

July 2004

Completion Date:

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular