Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma

NCT ID: NCT00559455

Last Updated: 2011-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-09-30
• Study Completion Date: 2010-01-31

Brief Summary

Primary objective:

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

Secondary objective:

To evaluate time to progression, 6month survival, overall survival, safety and tolerability of patients with hepatocellular carcinoma treated with the combination chemotherapy of Eloxatin+5-FU/LV

Conditions

Carcinoma, Hepatocellular

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Oxaliplatin

Intervention Type: DRUG

85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks

Fluorouracil

Intervention Type: DRUG

400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks

Leucovorin

Intervention Type: DRUG

200mg/m², Day 1 and Day 2; Every 2 weeks

Interventions

Oxaliplatin

85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks

Intervention Type: DRUG

Fluorouracil

400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks

Intervention Type: DRUG

Leucovorin

200mg/m², Day 1 and Day 2; Every 2 weeks

Intervention Type: DRUG

Eligibility Criteria

Exclusion Criteria

• Patients must have histologically confirmed hepatocellular carcinoma
• Patients must have measurable disease by CT scan
• Have not received previous palliative systemic chemotherapy for metastatic disease. (Adjuvant chemotherapy or radiation therapy for non target lesion can be allowed.)
• Patients progress after previous local treatment and at the time of randomization is at least 4 weeks after the last interventional therapy (Hepatic Artery Infusion, Trans-Artery Embolization or Trans-Artery Chemo-Embolization) or at least 4 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
• WHO 0-2 grades (Karnofsky Performance Score ≥ 70)
• Patients must have adequate organ and marrow function:

• Neutrophilus ≥ 1.5 x 10^9/L
• Platelets ≥ 75 x 10^9/L
• Asparagine AminoTransferase, Alanine AminoTransferase < 2.5 x Upper Normal Limit(UNL)
• Total Bilirubin ≤ 1.5 x UNL
• International Normalized Ratio < 1.5
• Child stage A or B
• Creatinine ≤ 1.5 X UNL

• Documented allergy to platinum compound or to other study drugs.
• Active Gastro-Intestinal bleeding and active haematologic malignancy
• Previous liver transplantation.
• Patients concomitantly receiving any other anti-cancer therapy.
• Patients who are receiving any other study treatments.
• Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
• History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
• Central nervous system metastasis
• Other serious illness or medical conditions
• Neuropathy ≥ grade 2

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sanofi

INDUSTRY

Sponsor Role: lead

Responsible Party

Sanofi-aventis Korea

Principal Investigators

Hyang Rim Kim

Role: STUDY_DIRECTOR

Sanofi

Locations

Sanofi-Aventis Administrative Office

Seoul, , South Korea

Countries

South Korea

Other Identifiers

OXALI_L_02859

Identifier Type: -

Identifier Source: org_study_id