Clinical trial NCT00471965: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Carcinoma, Hepatocellular
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-05-10
Enrollment: 371
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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


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.

Primary outcomes:
measure: Overall survival
timeFrame: From the date of randomization to the date of death due to any cause
Secondary outcomes:
measure: Time to progression
timeFrame: From the date of randomization to documentation of progression
measure: Response rate, secondary resection rate, quality of life
timeFrame: From the date of randomization to the end of study
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Sanofi-Aventis Administrative Office
city: Seoul
country: Korea, Republic of
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Bangkok
country: Thailand
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Benedict Blayney
role: STUDY_DIRECTOR
References:
citation: Qin S, Cheng Y, Liang J, Shen L, Bai Y, Li J, Fan J, Liang L, Zhang Y, Wu G, Rau KM, Yang TS, Jian Z, Liang H, Sun Y. Efficacy and safety of the FOLFOX4 regimen versus doxorubicin in Chinese patients with advanced hepatocellular carcinoma: a subgroup analysis of the EACH study. Oncologist. 2014 Nov;19(11):1169-78. doi: 10.1634/theoncologist.2014-0190. Epub 2014 Sep 15.