Phase II Study of Eloxatin+5-FU/LV in Patients With Unresectable Hepatocellular Carcinoma
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Oxaliplatin
85mg/m², 2 hours IV infusion, Day 1; Every 2 weeks
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
Drug: Leucovorin
200mg/m², Day 1 and Day 2; Every 2 weeks
|
Outcome Measures
Primary Outcome Measures
- 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
- Time to Progression (TTP), 6 month survival, overall survival, AFP [from the signature of Informed Consent up to end of the study]
Eligibility Criteria
Criteria
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)
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Total Bilirubin ≤ 1.5 x UNL
-
International Normalized Ratio < 1.5
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Child stage A or B
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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.
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Patients who are receiving any other study treatments.
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Pregnant or lactating women or women of childbearing potential without proper contraceptive methods.
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History of other malignant diseases, except cured basal cell carcinoma of skin and cured carcinoma in-situ of uterine cervix.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis Administrative Office | Seoul | Korea, Republic of |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Hyang Rim Kim, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- OXALI_L_02859