Sorafenib for Hepatocellular Cancer With Chronic Hepatitis C

Hepatocellular Cancer Clinical Trial

Official title:

A Prospective Study of HCV-RNA Kinetics During Treatment With Sorafenib in Patients With Advanced Hepatocellular Carcinoma and Chronic Hepatitis C

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01849588
• Other study ID #: 12-213
• Status: Recruiting
• Phase: Phase 4
• First received: May 6, 2013
• Last updated: March 19, 2014
• Start date: May 2013
• Est. completion date: September 2015

Study information

• Verified date: March 2014
• Source: Massachusetts General Hospital
• Contact: Andrew Zhu, MD, PhD
• Phone: 6177244000
• Email: azhu[@]partners.org
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: September 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis, Chronic
• Hepatocellular Cancer
• Liver Neoplasms

Intervention

Drug:
• Sorafenib

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Decrease AFP level > 20% from the baseline	Decrease AFP level > 20% from the baseline during treatment with sorafenib	2 years	No
Primary	Change in HCV-RNA level	Change in HCV-RNA level more than in 2 logs during treatment with sorafenib	2 years	No
Secondary	Time to radiological tumor progression	Time to radiological tumor progression	2 years	No
Secondary	Overall Survival	Overall survival	2 years	No