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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


Phase 3
18 Years
75 Years
Not Enrolling
Both
Carcinoma, Hepatocellular

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Overall survival

Outcome Time Frame:

From the date of randomization to the date of death due to any cause

Safety Issue:

No

Principal Investigator

Benedict Blayney

Investigator Role:

Study Director

Investigator Affiliation:

Sanofi

Authority:

China: Food and Drug Administration

Study ID:

OXALI_L_00858

NCT ID:

NCT00471965

Start Date:

March 2007

Completion Date:

March 2010

Related Keywords:

  • Carcinoma, Hepatocellular
  • Carcinoma
  • Carcinoma, Hepatocellular

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