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Comparing Efficacy of Sorafenib Versus Sorafenib in Combination With Low-dose FP in Patients With Advanced HCC

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ClinicalTrials.gov Identifier: NCT01214343
Recruitment Status : Unknown
Verified October 2010 by Ministry of Health, Labour and Welfare, Japan.
Recruitment status was:  Recruiting
First Posted : October 5, 2010
Last Update Posted : June 15, 2011
Sponsor:
Information provided by:
Ministry of Health, Labour and Welfare, Japan

Study Description
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Brief Summary:
The purpose of this study is to evaluate the efficacy of sorafenib in combination with low dose cisplatin /fluorouracil hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma.

Condition or disease Intervention/treatment Phase
Advanced Hepatocellular Carcinoma Carcinoma Carcinoma, Hepatocellular Liver Neoplasms Neoplasms Drug: Sorafenib with Low-dose FP Drug: Sorafenib Phase 3

Detailed Description:

Sorafenib with Low-dose FP Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days. Cisplatin at the dose of 20mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330mg/m2 will be administered continuously at day1-day5, and day8-day12 via the implanted catheter system.

Sorafenib Group

Sorafenib will be administered orally at a dose of 400 mg (2 x 200 mg tablets) twice daily (bid) for 28 days.

The treatment regimen will be continued until radiographic or symptomatic progression, the development of unacceptable toxicity.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 190 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial Comparing Efficacy of Sorafenib Versus Sorafenib In Combination With Low Dose Cisplatin /Fluorouracil Hepatic Arterial InfUSion Chemotherapy in Patients With Advanced Hepatocellular Carcinoma
Study Start Date : October 2010
Estimated Primary Completion Date : September 2013
Estimated Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Sorafenib

Arms and Interventions
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Arm Intervention/treatment
Experimental: Sorafenib with Low-dose FP Drug: Sorafenib with Low-dose FP
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in a cycle. Cisplatin at the dose of 20 mg/m2 will be administered at day 1 and day8, and fluorouracil at the dose of 330 mg/m2 will be administered continuously at day 1-day 5, and day8-day12 via the implanted catheter system. A cycle is defined as 28 days.
Other Names:
  • Nexavar
  • Low-dose FP
Active Comparator: Sorafenib Drug: Sorafenib
Sorafenib will be administered orally at a dose of 400 mg bid for 28 days in each cycle.A cycle is defined as 28 days.
Other Name: Nexavar


Outcome Measures
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Primary Outcome Measures :
  1. Overall survival [ Time Frame: Overall survival is defined as the time from randomization to death due to any cause ]

Secondary Outcome Measures :
  1. Time to progression [ Time Frame: TTP is defined as the time from randomization to radiological progression. ]
  2. Progression Free Survival [ Time Frame: PFS is defined as the time from randomization to radiological progression or death due to any cause ]
  3. Change of tumor marker [ Time Frame: Every 4-6 weeks ]
  4. Biomarker predicting the efficacy [ Time Frame: Pre and after treatment ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 20 Years and older.
  2. Life expectancy of at least 12 weeks at the pre-treatment evaluation.
  3. Advanced hepatocellular carcinoma with histological evidence on a biopsy specimen, or typical findings by dynamic CT or CT during hepatic arteriography/arterioportography.
  4. Not suitable for resection or local ablation therapy or transcatheter arterial chemoembolization.
  5. ECOG Performance status of 0 or 1.
  6. Cirrhotic status of Child-Pugh score ≤ 7.

  7. Adequate bone marrow, liver and renal function, as assessed by the following laboratory requirements:

    • Hemoglobin ≥8.5 g/dl
    • Granulocytes≥1500/μL
    • Platelet count ≥50,000 /μL
    • PT-INR ≤ 2.3
    • Total serum bilirubin ≤ 2 mg/dl
    • AST(SGOT) and ALT(SGPT) ≤ 6 × upper limit of normal
    • Serum creatinine ≤ 1.5 × upper limit of normal
    • Amylase ≤ 2 × upper limit of normal
  8. Written Informed Consent must be obtained.

Exclusion Criteria:

  1. Previous malignancy (except for cervical carcinoma in situ, adequate treated basal cell carcinoma, or superficial bladder tumors [Ta, Tis and T1], early gastric cancer, or other malignancies curatively treated > 3 years prior to entry
  2. Renal failure

  3. Any heart disease as follows

    • Congestive heart failure defined as NYHA class III or IV
    • Active coronary artery disease or ischemic heart disease such as cardiac infarction within 6 months prior to screening
    • Serious cardiac arrhythmia
    • Serious hypertension
  4. Active clinically serious infections except for HBV and HCV
  5. Active chicken pox.
  6. Auditory disorder.
  7. Known history of HIV infection.
  8. Known metastatic or meningeal tumors.
  9. Extrahepatic tumor spread which affects patient's prognosis
  10. History of seizure disorder.
  11. Clinically significant gastrointestinal bleeding within 4 weeks prior to study entry.
  12. Embolization or infarction such as transient ischemic disease, deep vein thrombosis, pulmonary embolization.

  13. Any history of treatment as follows:

    • Treatment with the agent which induces CYP3A4
    • Surgical procedure within 4 weeks prior to start of study drug
    • History of organ allograft
  14. Patients unable to swallow oral medications.
  15. Gastrointestinal disease that may affect to the absorption of drug or pharmacokinetics.
  16. Medication that may affect to the absorption of drug or pharmacokinetics.
  17. Any disease or disorder that may affect the evaluation of study drug.
  18. Entry to the other clinical trial within 4 weeks prior to entry to this study.
  19. Pregnant or breast-feeding patients.
  20. Known allergy to the investigational agent or any agent given in association with this trial.
  21. Substance abuse, medical, psychological or social conditions that, in the judgment of the investigator, is likely to interfere with the patient's participation in the study or evaluation of the stuy results.
  22. Any condition that is unstable or could jeopardize the safety of the patient and its compliance in the study, in the investigator's judgment.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01214343


Contacts
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Contact: Masatoshi Kudo, Professor +81-72-366-0221 ext 3149 m-kudo@med.kindai.ac.jp
Contact: Kazuomi Ueshima, Dr +81-72-366-0221 ext 3525 kaz-ues@med.kindai.ac.jp

Locations
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Sponsors and Collaborators
Ministry of Health, Labour and Welfare, Japan
Investigators
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Study Chair: Masatoshi Kudo, Professor Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Kinki University Faculty of Medicine, Department of Gastroenterology and Hepatology
ClinicalTrials.gov Identifier: NCT01214343    
Other Study ID Numbers: SILIUS Phase III trial
First Posted: October 5, 2010    Key Record Dates
Last Update Posted: June 15, 2011
Last Verified: October 2010
Keywords provided by Ministry of Health, Labour and Welfare, Japan:
sorafenib
Hepatic intraarterial infusion chemotherapy
HAIC
 Low dose FP
cisplatin
fluorouracil
Additional relevant MeSH terms:
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Carcinoma
Neoplasms
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Adenocarcinoma
Digestive System Neoplasms
 Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action