Sorafenib With TACE to Treat Hepatocellular Carcinoma (S-TACE)

This study has been completed.
Sponsor:
Information provided by:
University of Bern
ClinicalTrials.gov Identifier:
NCT00478374
First received: May 23, 2007
Last updated: November 1, 2010
Last verified: November 2010
  Purpose

The purpose of this study is to determine the feasibility to combine sorafenib with transarterial chemoembolisation in patients suffering from hepatocellular carcinoma.The hypothesis is that sorafenib may prevent the development and growth of tumoral lesions not treated by chemoembolisation.


Condition Intervention Phase
Hepatocellular Carcinoma
Drug: Sorafenib
Procedure: Transarterial chemoembolisation with doxorubicin
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Transarterial Chemoembolisation With Doxorubicin in Combination With Systemic Administration of Sorafenib for Patients With Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Bern:

Primary Outcome Measures:
  • To assess the safety and tolerability of the administration of sorafenib in patients with hepatocellular carcinoma treated with TACE by determining the MTD. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • tumor volumetry [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • changes in the blood concentration of tumor marker AFP [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: May 2007
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Sorafenib
Sorafenib 400mg bid
Procedure: Transarterial chemoembolisation with doxorubicin
Transarterial chemoembolisation (TACE)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with inoperable HCC, who are candidates for transarterial chemoembolization (TACE).
  • Diagnosis of hepatocellular carcinoma based on the EASL's criteria (1).
  • Child-Pugh score < 10 (Child A or B),
  • Life expectancy superior to 12 weeks at the pre-treatment evaluation.
  • Local therapies have been interrupted for at least 4 weeks
  • Written informed consent signed
  • Age >= 18
  • Performance status ECOG 0-1
  • Normal organ and marrow function defined as:

    • Haematopoietic: absolute neutrophil count >1,500/mm3, platelet count > 60,000/mm3, haemoglobin > 9g/dL
    • INR < 1.5 ULN and PTT within normal limits
    • Hepatic: AST or ALT < 5 x ULN
    • Renal: creatinine < 1.5 x ULN
  • Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to the start of treatment
  • Women of childbearing potential and men must agree to use adequate birth contraception (must be double and methods recorded) prior to study entry and for the duration of the study participation. For both men and women, these adequate birth control measures must be used for at least 3 months after the last administration of study drug.

Exclusion Criteria:

  • Active heart disease is defined as congestive heart failure >NYHA (New York Heart Association) class 2; active coronary artery disease (myocardial infarction more than 6 months prior to study entry is allowed); cardiac arrhythmias requiring anti-arrhythmic therapy (beta-blockers or digoxin are permitted) or uncontrolled hypertension.

    • Congestive heart failure, serious cardiac arrhythmia, active coronary artery disease.
    • Thrombotic or embolic events within the past 6 months such as a cerebrovascular accident (including transient ischemic attacks), pulmonary embolism.
    • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection.
    • Psychiatric illness/social situations that would limit compliance with study requirements.
    • Patients with evidence of active infection will become eligible for reconsideration 7 days after completing antibiotic therapy.
    • HIV-positive patients receiving combination anti-retroviral therapy are excluded from the study because of possible pharmacokinetic interactions with sorafenib.
    • Patients who have been treated with sorafenib.
    • Cerebral metastasis.
    • Child-Pugh score C.
    • Hypertension defined as systolic blood pressure greater than 150 mmHg or diastolic pressure greater than 90 mmHg despite optimal medical management.
    • Proteinuria defined as a 24-hour urine protein excretion greater than 1000 mg. Urine dipstick proteinuria of 1+ or greater will require a 24-hour urine to determine eligibility for enrolment.
    • Therapeutic anticoagulation with coumarin, heparins, or heparinoids.
    • Serious non-healing wounds (including wounds healing by secondary intention), acute or non-healing ulcers, or bone fractures within 3 months of fracture.
    • Evidence of bleeding diathesis.
    • Impairment of swallowing that would preclude administration of sorafenib.
    • History of haemoptysis or surgery within the past 28 days.
    • Organ allograft.
    • Pregnant or breastfeeding patients.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00478374

Locations
Switzerland
Inselspital
Bern, Switzerland, 3010
Sponsors and Collaborators
University of Bern
Investigators
Principal Investigator: Daniel Candinas Inselspital
Principal Investigator: Markus Borner Inselspital
Study Director: Jean-François J Dufour, MD Inselspital
  More Information

No publications provided by University of Bern

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: J-F DUFOUR, University of Bern
ClinicalTrials.gov Identifier: NCT00478374     History of Changes
Other Study ID Numbers: JFD-12581
Study First Received: May 23, 2007
Last Updated: November 1, 2010
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Doxorubicin
Liposomal doxorubicin
Sorafenib
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on August 28, 2014