Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

NCT ID: NCT01005875

Last Updated: 2017-05-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2013-06-30

Brief Summary

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

Conditions

Hepatocellular Carcinoma; Liver Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Radiation followed by Sorafenib

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Group Type: EXPERIMENTAL

Sorafenib

Intervention Type: DRUG

Nexavar in bottles of 120 tables

Stereotactic Body Radiotherapy (SBRT)

Intervention Type: RADIATION

SBRT

Interventions

Sorafenib

Nexavar in bottles of 120 tables

Intervention Type: DRUG

Stereotactic Body Radiotherapy (SBRT)

SBRT

Intervention Type: RADIATION

Other Intervention Names

BAY 43-9006; Nexavar

Eligibility 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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma

INDUSTRY

Sponsor Role: collaborator

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kimberly Keene

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kimberly S Keene, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F090910004

Identifier Type: -

Identifier Source: org_study_id