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

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

Overview[ - collapse ][ - ]

Purpose	Primary: - Overall Survival (OS) Secondary: - Time to Tumor Progression (TTP) - Response Rate (RR) - Improvement of Quality of Life (QoL) - Safety - Secondary resection rate
Condition	Carcinoma, Hepatocellular
Intervention	Drug: Oxaliplatin + 5-Fluorouracil/Leucovorin Drug: Doxorubicin
Phase	Phase 3
Sponsor	Sanofi
Responsible Party	Sanofi
ClinicalTrials.gov Identifier	NCT00471965
First Received	May 9, 2007
Last Updated	September 17, 2010
Last verified	September 2010

Tracking Information[ + expand ][ + ]

First Received Date	May 9, 2007
Last Updated Date	September 17, 2010
Start Date	March 2007
Estimated Primary Completion Date	March 2010
Current Primary Outcome Measures	Overall survival [Time Frame: From the date of randomization to the date of death due to any cause] [Designated as safety issue: No]
Current Secondary Outcome Measures	Time to progression [Time Frame: From the date of randomization to documentation of progression] [Designated as safety issue: No] Response rate, secondary resection rate, quality of life [Time Frame: From the date of randomization to the end of study] [Designated as safety issue: No]

Descriptive Information[ + expand ][ + ]

Brief Title	Oxaliplatin + 5-FluoroUracil/LeucoVorin (5-FU/LV) (FOLFOX4) Versus Doxorubicin as Palliative Chemotherapy in Advanced Hepatocellular Carcinoma Patients
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
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
Detailed Description	Not Provided
Study Type	Interventional
Study Phase	Phase 3
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	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 Drug: Doxorubicin Day 1: Doxorubicin 50mg/m² iv infusion. Repeated every 3 weeks.
Study Arm (s)	Experimental: A Oxaliplatin + 5-Fluorouracil/Leucovorin Active Comparator: B Doxorubicin

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	371
Estimated Completion Date	March 2010
Estimated Primary Completion Date	March 2010
Eligibility Criteria	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-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.
Gender	Both
Ages	18 Years
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	China, Korea, Republic of, Taiwan, Thailand

Administrative Information[ + expand ][ + ]

NCT Number	NCT00471965
Other Study ID Numbers	OXALI_L_00858
Has Data Monitoring Committee	No
Information Provided By	Sanofi
Study Sponsor	Sanofi
Collaborators	Not Provided
Investigators	Study Director: Benedict Blayney Sanofi
Verification Date	September 2010

Locations[ + expand ][ + ]

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