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

Phase 2

Completed

• Conditions: Carcinoma, Hepatocellular
• Interventions: Drug: Oxaliplatin; Drug: Fluorouracil; Drug: Leucovorin

• Registration Number: NCT00559455
• Lead Sponsor: Sanofi

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

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09
• Study First Submitted: 2007-11-15
• Study First Submitted QC: 2007-11-15
• Study First Posted: 2007-11-16
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-27
• Last Update Posted: 2011-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

Not provided

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Fluorouracil	-
1	Oxaliplatin	-
1	Leucovorin	-

Primary Outcome Measures

Name	Time	Method
Tumor Response Rate evaluated using RECIST (Response Evaluation Criteria in Solid Tumors) by physical examination, chest X-ray, abdomen-pelvis CT (Computed tomography) scan	every 6 weeks

Secondary Outcome Measures

Name	Time	Method
Time to Progression (TTP), 6 month survival, overall survival, AFP	from the signature of Informed Consent up to end of the study

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇰🇷 Seoul, Korea, Republic of