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HCV-RNA Kinetics During Sorafenib for Hepatocellular Carcinoma (HCC)

This study has been terminated.
(Slow Accrual)
Sponsor:
Information provided by (Responsible Party):
Andrew X. Zhu, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01849588
First received: May 6, 2013
Last updated: January 23, 2017
Last verified: January 2017
  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: Intervention Model: Single Group Assignment
Masking: No masking
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: up to 2 years ]
    Successful decline in HCV (hepatitis C virus)-RNA level, with success defined as a decrease of at least two logs of HCV-RNA between baseline and any subsequent measurement.


Secondary Outcome Measures:
  • Time to Radiological Tumor Progression [ Time Frame: 2 years ]
    Time to radiological tumor progression is defined as the time period between enrollment and the earlier of tumor progression and death. Participants who are alive and progression-free at the date of last contact will be censored at this date.

  • Overall Survival [ Time Frame: 2 years ]
    Overall survival is defined as the time period between enrollment and the date of death. Participants who are still alive at last contact will be censored at this date.


Other Outcome Measures:
  • Decrease Alpha-fetoprotein(AFP) Level > 20% From the Baseline [ Time Frame: 2 years ]
    The proportion of participants with a decrease of greater than 20% in AFP (alpha-fetoprotein) level between baseline and any subsequent measurement following treatment with sorafenib will be reported.


Enrollment: 3
Study Start Date: May 2013
Study Completion Date: January 2017
Primary Completion Date: December 2016 (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:

This is a prospective, open-label, non-interventional trial to evaluate HCV-RNA levels during treatment with Sorafenib in patients with advanced hepatocellular carcinoma.

Participants will receive Sorafenib 400mg orally twice daily. HCV-RNA (Hepatitis C Virus - Ribonucleic Acid) levels will be measured at baseline, week 2 of sorafenib, week 4 of sorafenib, week 6 of sorafenib, week 8 of sorafenib, week 12 of sorafenib, and 2 weeks after discontinuing sorafenib. HCV-RNA levels will be measured by drawing about 2 tablespoons of blood

During the study period, tumor assessments will be done by MRI (magnetic resonance imaging) or CT (computed tomography) scans at baseline and every 8 weeks.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02214
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Andrew Zhu, MD, PhD Massachusetts General Hospital
  More Information

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
Results First Received: January 23, 2017
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by Massachusetts General Hospital:
Hepatitis C positive

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

ClinicalTrials.gov processed this record on March 27, 2017