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

October 30, 2009
January 23, 2013
November 2009
December 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01005875 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma
RAD 0901- Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

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

Not Provided
Interventional
Not Provided
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hepatocellular Carcinoma
  • Liver Cancer
  • Drug: Sorafenib
    Nexavar in bottles of 120 tables
    Other Names:
    • BAY 43-9006
    • Nexavar
  • Radiation: Stereotactic Body Radiotherapy (SBRT)
    SBRT
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
5
June 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
19 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01005875
F090910004
Yes
Dr. Kimberly Keene, University of Alabama at Birmingham
University of Alabama at Birmingham
Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma
Principal Investigator: Kimberly S Keene, MD University of Alabama at Birmingham
University of Alabama at Birmingham
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP