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

Study Overview
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Brief Summary
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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

Official Title
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Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma

Conditions
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Carcinoma, Hepatocellular

Intervention / Treatment
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* Drug: Oxaliplatin
* Drug: Fluorouracil
* Drug: Leucovorin


Participation Criteria
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Eligibility Criteria
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Lists of Inclusion and 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 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Oxaliplatin<br>* 85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks<br>Drug: Fluorouracil<br>* 400mg/m², 2 hours IV bolus, Day 1; 22 hours continuous IV infusion 600mg/m², Day 1 and Day 2; Every 2 weeks<br>Drug: Leucovorin<br>* 200mg/m², Day 1 and Day 2; Every 2 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Progression (TTP), 6 month survival, overall survival, AFP |  | from the signature of Informed Consent up to end of the study |