Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients

Carcinoma, Hepatocellular Clinical Trial

— EACH  

Official title:

Oxaliplatin(Eloxatin®) + 5-FU/LV (FOLFOX4) Compared With Single Agent Doxorubicin (Adriamycin®) as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients Ineligible for Curative Resection or Local Treatment

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00471965
• Other study ID #: OXALI_L_00858
• Status: Completed
• Phase: Phase 3
• First received: May 9, 2007
• Last updated: September 17, 2010
• Start date: March 2007
• Est. completion date: March 2010

Study information

• Verified date: September 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

Primary:

• Overall Survival (OS)

Secondary:

• Time to Tumor Progression (TTP)

• Response Rate (RR)

• Improvement of Quality of Life (QoL)

• Safety

• Secondary resection rate

Recruitment information / eligibility

• Status: Completed
• Enrollment: 371
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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-a 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular

Intervention

Drug:
• Oxaliplatin + 5-Fluorouracil/Leucovorin
Day 1: Oxaliplatin 85mg/m² 2h IV infusion, leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m2 22h IV infusion. Day 2: Leucovorin 200mg/m² 2h IV infusion, 5-fluorouracil 400mg/m² IV bolus, 5-fluorouracil 600mg/m² 22h IV infusion. Repeated every 2 weeks
• Doxorubicin
Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.

Locations

Country	Name	City	State
China	Sanofi-Aventis Administrative Office	Shanghai
Korea, Republic of	Sanofi-Aventis Administrative Office	Seoul
Taiwan	Sanofi-Aventis Administrative Office	Taipei
Thailand	Sanofi-Aventis Administrative Office	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

China,  Korea, Republic of,  Taiwan,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival		From the date of randomization to the date of death due to any cause	No
Secondary	Time to progression		From the date of randomization to documentation of progression	No
Secondary	Response rate, secondary resection rate, quality of life		From the date of randomization to the end of study	No