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Study of Bavituximab and Sorafenib In Patients With Advanced Liver Cancer

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01264705
First Posted: December 22, 2010
Last Update Posted: June 1, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Texas Southwestern Medical Center
  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: Intervention Model: Single Group Assignment
Masking: None (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:


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. ]
  • 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. ]

Secondary Outcome Measures:
  • Overall Survival. [ Time Frame: 2 years ]

Estimated Enrollment: 56
Study Start Date: January 2011
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01264705


Locations
United States, Texas
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Adam C Yopp, MD UT Southwestern Medical Center
  More Information

Responsible Party: University of Texas Southwestern Medical Center
ClinicalTrials.gov Identifier: NCT01264705     History of Changes
Other Study ID Numbers: STU 062010-150
First Submitted: December 1, 2010
First Posted: December 22, 2010
Last Update Posted: June 1, 2016
Last Verified: May 2016

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

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Liver Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases
Sorafenib
Niacinamide
Antibodies, Monoclonal
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Immunologic Factors