Sorafenib for Hepatocellular Cancer With Chronic Hepatitis C

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01849588
First received: May 6, 2013
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

This research study is a Phase IV clinical trial. Phase IV trials are used to further test and monitor the safety of a drug approved by the FDA and to see if the drug has any other indications that can be used to treat different diseases.

Sorafenib is a new drug, which is approved under the brand name Nexavar for the treatment of liver cancer. It is also currently being tested in various other cancers. Sorafenib works by slowing down and/or stopping the development of new cancer cells and new blood vessels. By slowing down and/or stopping the growth of new blood vessels around a tumor, it is believed that sorafenib prevents or slows down the growth of tumors.

The researchers of this study would like to study the effects of sorafenib on hepatitis C by drawing additional research blood samples from people infected with hepatitis C who are receiving sorafenib treatment for liver cancer. These tests will measure certain proteins in the blood (HCV-RNA) which may indicate if sorafenib has any effect on the hepatitis C virus.


Condition Intervention Phase
Hepatocellular Cancer
Drug: Sorafenib
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Change in HCV-RNA level [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Change in HCV-RNA level more than in 2 logs during treatment with sorafenib


Secondary Outcome Measures:
  • Time to radiological tumor progression [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Time to radiological tumor progression

  • Overall Survival [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Overall survival


Other Outcome Measures:
  • Decrease AFP level > 20% from the baseline [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Decrease AFP level > 20% from the baseline during treatment with sorafenib


Estimated Enrollment: 20
Study Start Date: May 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Sorafenib taken orally twice per day
Drug: Sorafenib
Other Name: Nexavar

Detailed Description:

If you agree to participate in this study, you will be asked to undergo some screening tests or procedures to confirm that you are eligible. Many of these tests and procedures are likely to be part of regular cancer care and may be done even if it turns out that you do not take part in the research study. If you have had some of these tests or procedures recently, they may or may not have to be repeated. These tests include: a medical history, hepatitis C genotype test, performance status, tumor assessment, blood tests and a urine test. If these tests show that you are eligible to participate in the research study, you will begin the study treatment. If you do not meet the eligibility criteria, you will not be able to participate in this research study.

If you take part in this research study, you will be given a sorafenib study drug-dosing diary for each treatment cycle. Each treatment cycle lasts 28 days (4 weeks), during which time you will be taking the study drug twice daily. The diary will also include special instructions for sorafenib.

During all cycles you will have a physical exam and you will be asked questions about your general health and specific questions about any problems that you might be having and any medications you may be taking. Your blood pressure will be monitored on the day you receive your first dose of sorafenib and then at weeks 2,4,6 and 8 during sorafenib treatment.

The following blood tests will be performed as part of the research study: HCV RNA levels-about 2 tablespoons of blood will be drawn to check the levels of hepatitis C in your blood (HCV RNA) to see if sorafenib is having an affect. These tests will be completed at the following times: one week before you receive your first dose of sorafenib, at weeks 2,4,8 and 12 during sorafenib treatment, and then 2 weeks after your last dose. AFB Biomarkers-about 2 tablespoons of blood will be drawn to test for a protein called alpha fetoprotein (AFP), which the researchers use to measure how your body responds to treatment (biomarker). These tests will be completed at the following times: at weeks, 2,4,8 and 12 during sorafenib treatment, and then 2 weeks after your last dose.

We will assess your tumor by CT or MRI scan once every 8 weeks.

After the final dose of study drug we will ask you to return to the clinic once every 2 weeks for the following procedures: Medical review, blood pressure, performance status and research blood tests (HCV RNA and AFP). We would like to keep track of your medical condition for the rest of your life. We would like to do this by calling you on the telephone once a year to see how your are doing. Keeping in touch with you and checking your condition every year helps us look at the long-term effects of the research study.

  Eligibility

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

Inclusion Criteria:

  • Histologically and/or radiologically confirmed advanced HCC
  • Detectable HCV RNA with anti-HCV-positivity
  • Life expectancy of at least 3 months
  • Willing to use adequate contraception

Exclusion Criteria:

  • Pregnant or breastfeeding
  • Undetectable HCV RNA
  • Uncontrolled hypertension
  • Active or clinically significant cardiac disease
  • Thrombolic, embolic, venous or arterial events within 6 months of informed consent
  • Pulmonary hemorrhage/bleeding event (NCI-CTCAE grade 2 or higher) within 4 weeks before study entry
  • Previously untreated or concurrent cancer except cervical cancer in situ, treated basal cell carcinoma or superficial bladder tumor
  • Presence of non-healing wound, ulcer or bone fracture
  • History of organ allograft
  • Known or suspected allergy or hypersensitivity to any of the study drugs
  • Any malabsorption condition
  • Inability to comply with the protocol and/or not willing or not available for follow up
  • Major surgery within 30 days prior to start of study drug
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01849588

Contacts
Contact: Andrew Zhu, MD, PhD 6177244000 azhu@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02214
Contact: Andrew Zhu, MD, PhD    617-724-4000    azhu@partners.org   
Principal Investigator: Andrew Zhu, MD, PhD         
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02215
Contact: Thomas Abrams, MD    617-632-6932    tabrams1@partners.org   
Principal Investigator: Thomas Abrams, MD         
Dana-Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Thomas Abrams, MD    617-632-6932    tabrams1@partners.org   
Principal Investigator: Thomas Abrams, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Andrew Zhu, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Andrew X. Zhu, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01849588     History of Changes
Other Study ID Numbers: 12-213
Study First Received: May 6, 2013
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
Hepatitis C positive

Additional relevant MeSH terms:
Hepatitis
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Neoplasms
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Flaviviridae Infections
RNA Virus Infections
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Sorafenib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on October 19, 2014