Stereotactic Radiation Therapy and Sorafenib in the Treatment of Hepatocellular Carcinoma

NCT01005875 | Terminated Results DMC

• 1 other identifier: F090910004
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Keywords

Hepatocellular carcinoma; HCC; Liver Cancer; adult primary hepatocellular carcinoma

Outcome Measures

Primary Outcomes (1)

• Determine the Safety and Tolerability of Sequential SBRT and Sorafenib in Patients With Unresectable Hepatocellular Carcinoma

  Number of subjects experiencing a Grade 5 toxicity related to SBRT and sorafenib

  between baseline and 3 years

Secondary Outcomes (4)

• The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Tumor Volume

  baseline, 4 weeks and 10 weeks

• The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Ktrans (Volume Transfer Coefficient).

  baseline, 4 weeks and 10 weeks

• The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by Kep. Kep Describes How Fast Contrast Can Redistribute in Tissue.

  baseline, 4 weeks after baseline and 10 weeks post baseline

• The Degree of Change in Necrosis and Vascular Permeability Via Dynamic Contrast Enhanced (DCE) and Diffusion-weighted Imaging (DWI) Magnetic Resonance Imaging (MRI) as Measured by ADC (Apparent Diffusion Coefficient).

  baseline, 4 weeks post baseline, 10 weeks post baseline

Study Arms (1)

Radiation followed by Sorafenib

EXPERIMENTAL

Radiation therapy, stereotactic body radiation therapy followed by Sorafenib

Drug: Sorafenib; Radiation: Stereotactic Body Radiotherapy (SBRT)

Interventions

Sorafenib DRUG

Nexavar in bottles of 120 tables

Also known as: BAY 43-9006, Nexavar

Radiation followed by Sorafenib

Stereotactic Body Radiotherapy (SBRT) RADIATION

SBRT

Radiation followed by Sorafenib

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• Bayer Healthcare Pharmaceuticals, Inc./Bayer Schering Pharma: collaborator

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms

Interventions

Sorafenib; Radiosurgery

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Phenylurea Compounds; Urea; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Niacinamide; Nicotinic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Radiotherapy; Therapeutics; Stereotaxic Techniques; Neurosurgical Procedures; Surgical Procedures, Operative; Investigative Techniques

Limitations and Caveats

The study was closed due to slow accural and enrolled 5 of the 10 planned patients.

Results Point of Contact

• Title: Dr. Kimberly Keene
• Organization: University of Alabama at Birmingham

kkeene@uab.edu

2-5-934-5670

Study Officials

• Kimberly S Keene, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 30, 2009
• First Posted: November 2, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: June 1, 2013
• Last Updated: May 10, 2017
• Results First Posted: June 11, 2014

Record last verified: 2017-04

Locations

US (1)