Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma (RAD 0901)

This study has been terminated.
(Sponsor(Bayer)did not wish to continue with study due to slow accrual. Therefore, there is insufficient data and will not be any study results/outcomes.)
Sponsor:
Collaborator:
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Information provided by (Responsible Party):
Dr. Kimberly Keene, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01005875
First received: October 30, 2009
Last updated: January 23, 2013
Last verified: January 2013
  Purpose

This study is to determine the safety and efficacy of stereotactic body radiotherapy (SBRT) and treatment drug in patients with hepatocellular carcinoma.


Condition Intervention
Hepatocellular Carcinoma
Liver Cancer
Drug: Sorafenib
Radiation: Stereotactic Body Radiotherapy (SBRT)

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Determine the safety and tolerability of sequential SBRT and sorafenib in patients with unresectable hepatocellular carcinoma [ Time Frame: 3 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Characterize the degree of alteration in necrosis and vascular permeability via dynamic contrast enhanced (DCE) and diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Enrollment: 5
Study Start Date: November 2009
Estimated Study Completion Date: June 2013
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Sorafenib
    Nexavar in bottles of 120 tables
    Other Names:
    • BAY 43-9006
    • Nexavar
    Radiation: Stereotactic Body Radiotherapy (SBRT)
    SBRT
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Child-Pugh class A or B7 cirrhosis.
  • No prior radiation therapy to the upper right abdominal quadrant.
  • Size of each tumor less than 6 cm.
  • Three or less known lesions.
  • More than 800 cc of uninvolved liver.
  • Age > 19 years old
  • ECOG Performance Status 0 or 1
  • Adequate bone marrow, liver and renal function as assessed by the following:
  • Hemoglobin > 8.5 g/dl
  • Platelet count > 50,000/mm3
  • Total bilirubin < 1.5 times ULN
  • ALT and AST < 2.5 times the ULN ( < 5 x ULN for patients with liver involvement)
  • Creatinine < 1.5 times 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 contraception (barrier method of birth control) prior to study entry and for the duration of study participation. Men should use adequate birth control for at least three months after the last administration of sorafenib.
  • Ability to understand and the willingness to sign a written informed consent. A signed informed consent must be obtained prior to any study specific procedures.
  • INR < 1.5 or a PT/PTT within normal limits. Patients receiving anti-coagulation treatment with an agent such as warfarin or heparin may be allowed to participate. For patients on warfarin, the INR should be measured prior to initiation of sorafenib and monitored at least weekly, or as defined by the local standard of care, until INR is stable.

Exclusion Criteria:

  • Child-Pugh class B8 or C cirrhosis.
  • ECOG greater than or equal to 2.
  • Uncontrolled ascites despite medical management.
  • Less than 800 cc of uninvolved liver.
  • Prior radiotherapy to the upper abdominal quadrant.
  • Prior antiangiogenic or tyrosine kinase inhibitor therapy Cardiac disease: Congestive heart failure > class II NYHA. Patients must not have unstable angina(anginal symptoms at rest) or new onset angina (began within the last 3 months) or myocardial infarction within the past 6 months.
  • Known brain metastasis. Patients with neurological symptoms must undergo a CT scan/MRI of the brain to exclude brain metastasis.
  • Cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Uncontrolled hypertension defined as systolic blood pressure > 150 mmHg or diastolic pressure >90 mmHg, despite optimal medical management.
  • Known human immunodeficiency virus (HIV) infection or chronic Hepatitis B or C.
  • Active clinically serious infection > CTCAE Grade 2.
  • Thrombolic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.
  • Pulmonary hemorrhage/bleeding event > CTCAE Grade 2 within 4 weeks of first dose of study drug.
  • Any other hemorrhage/bleeding event > CTCAE Grade 3 within 4 weeks of first dose of study drug.
  • Serious non-healing wound, ulcer, or bone fracture.
  • Evidence or history of bleeding diathesis or coagulopathy
  • Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.
  • Use of St. John's Wort or rifampin (rifampicin).
  • Known or suspected allergy to sorafenib or any agent given in the course of this trial.
  • Any condition that impairs patient's ability to swallow whole pills.
  • Any malabsorption problem.
  • Pregnant or lactating female.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01005875

Locations
United States, Alabama
UAB
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Investigators
Principal Investigator: Kimberly S Keene, MD University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: Dr. Kimberly Keene, Assistant Professor, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01005875     History of Changes
Other Study ID Numbers: F090910004
Study First Received: October 30, 2009
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
Hepatocellular carcinoma
HCC
Liver Cancer
adult primary hepatocellular carcinoma

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

ClinicalTrials.gov processed this record on April 17, 2014