Status:
COMPLETED
Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients
Lead Sponsor:
Sanofi
Conditions:
Carcinoma, Hepatocellular
Eligibility:
All Genders
18-75 years
Phase:
PHASE3
Brief Summary
Primary: * Overall Survival (OS) Secondary: * Time to Tumor Progression (TTP) * Response Rate (RR) * Improvement of Quality of Life (QoL) * Safety * Secondary resection rate
Eligibility Criteria
Inclusion
- Histologically, cytologically or clinically diagnosed (in patient with cirrhosis, Alpha-Fetoprotein(AFP)≥400μg/L and morphological evidence \[contrast Computed Tomography(CT)/Magnetic Resonance Imaging(MRI)\] of hypervascular liver tumor, elevated AFP level due to other reasons \[germ cell carcinoma, progressive chronic hepatitis, pregnancy, etc\] can be excluded) unresectable hepatocellular carcinoma, ineligible or if the patient does not consent to receive local invasive treatment (chemo-embolism, ablation, etc.).
- At least one measurable lesion (on CT: ≥2cm, on spiral CT or MRI ≥1cm)
- Have not received previous palliative systemic chemotherapy for metastatic disease. If the patient received previous systemic chemotherapy as adjuvant treatment, he must have been completed at least 12 months previously.
- 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 8 weeks after the last radiotherapy/ablation/ Percutaneous Ethanol Injection to the target lesion.
- Karnofsky Performance Score≥70, Barcelona of Cancer Liver Category stage B/C
- Patients must have adequate organ and marrow function:
- Neutrophilus≥1.5X10\^9/L
- Platelets≥75X10\^9/L
- Asparagine AminoTransferase,Alanine AminoTransferase\<2.5 Upper Normal Limit(UNL)
- Total Bilirubin\<1.5 UNL
- International Normalized Ratio\<1.5
- Child stage A or B
- Normal base line Left Ventricular Ejection Fraction (LVEF result must be above or equal to the lower limit of normal for the institution)
Exclusion
- Documented allergy to platinum compound or to other study drugs.
- Any previous oxaliplatin or doxorubicin treatment, except adjuvant treatment more than 12 months before the randomization.
- Previous liver transplantation.
- Patients concomitantly receiving any other anti-cancer therapy, including interferon-α and herbal medicine which was approved by local authority to be used as "anti-cancer" medicine, except radiotherapy to non-target lesion (bone metastasis, etc)
- 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
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
371 Patients enrolled
Trial Details
Trial ID
NCT00471965
Start Date
March 1 2007
End Date
March 1 2010
Last Update
September 20 2010
Active Locations (4)
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1
Sanofi-Aventis Administrative Office
Shanghai, China
2
Sanofi-Aventis Administrative Office
Seoul, South Korea
3
Sanofi-Aventis Administrative Office
Taipei, Taiwan
4
Sanofi-Aventis Administrative Office
Bangkok, Thailand