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Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

This study is currently recruiting participants.
Verified October 2010 by University of Texas Southwestern Medical Center
Sponsor:
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier:
NCT01264705
First received: December 1, 2010
Last updated: December 27, 2011
Last verified: October 2010
History of Changes
  Purpose

This is a non-randomized, open-label, single-institution phase I/II therapeutic trial of bavituximab and sorafenib in patients with advanced hepatocellular carcinoma (HCC). This study will be activated at the UT Southwestern Medical Center, comprised of The Harold C. Simmons Comprehensive Cancer Center, UT Southwestern Hospitals-St. Paul and Parkland Memorial Hospital System. Advanced HCC is defined as disease that is not amenable to surgical resection or orthotopic liver transplantation or is metastatic in nature.


Condition Intervention Phase
Hepatocellular Carcinoma
Liver Cancer
 Drug: bavituximab and sorafenib
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase I/II Study of Bavituximab and Sorafenib In Patients With Advanced Hepatocellular Carcinoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Liver Cancer
U.S. FDA Resources

Further study details as provided by University of Texas Southwestern Medical Center:

Primary Outcome Measures:
  • Safety as measured by the number of participants with adverse events. [ Time Frame: The phase I component is expected to be complete within 3 months. ] [ Designated as safety issue: Yes ]
  • Time to Progression (phase II)as measured by abdominal magnetic resonance imaging. [ Time Frame: The phase II component is expected to be complete within 2 years. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Overall Survival. [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 56
Study Start Date: November 2010
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bavituximab and Sorafenib Drug: bavituximab and sorafenib
Bavituximab:0.3,1.0,and 3.0 mg/kg weekly Sorafenib: 400mg PO twice daily

Detailed Description:

The investigators are looking for men or women aged 18 years or older with hepatocellular carcinoma not suitable for surgical resection or hepatic transplantation. Prior locoregional therapy including but not limited to transarterial chemoembolization (TACE), radiofrequency ablation (RFA) or ethanol injection is allowed as long as the treatment was 4 weeks previous. Patients must be Child-Pugh A with no previous treatment with sorafenib or other vascular endothelial growth factor (VEGF) inhibitors.

  Eligibility

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

Inclusion Criteria:

  1. Patients must have a diagnosis of hepatocellular carcinoma by at least one criterion listed below:

    • Histologically confirmed.
    • MRI or CT consistent with liver cirrhosis and at least one solid liver lesion >2 cm with early enhancement and delayed enhancement washout regardless of AFP.
    • AFP >400 ng/ml and evidence of at least one solid liver lesion >2 cm regardless of specific imaging characteristics on CT or MRI.
  2. Locally advanced or metastatic disease.
  3. Patients with locally advanced disease must have disease deemed to be unresectable or not eligible for hepatic transplantation. Determination will occur in the weekly GI DMT meeting by surgical oncologists and transplant surgeons.
  4. Measurable disease, as defined as lesions that can accurately be measured in at least one dimension (longest diameter to be measured) according to Response Evaluation Criteria in Solid Tumors (RECIST, version 1.1) at least 2 cm with conventional techniques or at least 1 cm with spiral computed tomography.
  5. Child-Pugh Score A.
  6. Age ≥ 18 years.
  7. Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-2.
  8. Absolute neutrophil count ≥ 1,500 cells/mm3.
  9. Platelet count ≥ 75,000 cells/mm3.
  10. Total bilirubin ≤ 3.0 mg/dl.
  11. Hemoglobin ≥ 8.5 g/dl.
  12. AST and ALT ≤ 5.0 times upper limit of normal.
  13. D-dimer ≤ 3 times upper limit of normal.
  14. INR ≤ 1.8 (therapeutic anticoagulation allowed as long as medically indicated.

Exclusion Criteria:

  1. History of bleeding diathesis or coagulopathy.
  2. Symptomatic or clinically active brain metastases.
  3. Major surgery within previous 4 weeks.
  4. History of thromboembolic events (including both pulmonary embolisms and deep vein thrombosis); central venous catheter-related thrombosis > 6 months prior is allowed.
  5. Prior adjuvant therapy with sorafenib or other Raf/MEK/RAS or VEGFR inhibitors. Prior adjuvant therapy is allowed provided it was completed > 6 months ago and there is documented recurrence of hepatocellular carcinoma.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01264705

Locations
United States, Texas
UT Southwestern Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: Adam C Yopp, MD         adam.yopp@utsouthwestern.edu    
Principal Investigator: Adam C Yopp, MD            
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Adam C Yopp, MD UT Southwestern Medical Center
  More Information

No publications provided

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01264705     History of Changes
Other Study ID Numbers: 062010-150
Study First Received: December 1, 2010
Last Updated: December 27, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Texas Southwestern Medical Center:
Cirrhosis
GI Cancer
Hepatitis
Oncology

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
Antibodies, Monoclonal
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013