Carcinoma, Hepatocellular Clinical Trial
Official title:
Phase II Study of Oxaliplatin + 5-FluoroUracil/Leucovorin (Eloxatin+5-FU/LV) in Patients With Unresectable Hepatocellular Carcinoma
Verified date | June 2011 |
Source | Sanofi |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
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
Status | Completed |
Enrollment | 38 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 75 Years |
Eligibility |
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. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Sanofi-Aventis Administrative Office | Seoul |
Lead Sponsor | Collaborator |
---|---|
Sanofi |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No | |
Secondary | Time to Progression (TTP), 6 month survival, overall survival, AFP | from the signature of Informed Consent up to end of the study | No |
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