Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Registry Information

Alternate Title

Phase I/II Randomized Study of Sorafenib Tosylate and Bevacizumab as First-Line Therapy in Patients With Locally Advanced or Metastatic Hepatocellular Carcinoma (Phase I Closed to Accrual as of 11/03/2010)

Basic Trial Information

Special Category: ACTNOW

Trial Description

Purpose:

Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Bevacizumab and sorafenib may also stop the growth of liver cancer by blocking blood flow to the tumor.

This randomized phase I/II trial is studying the best dose of bevacizumab when given together with sorafenib as first-line therapy in treating patients with locally advanced or metastatic liver cancer.(Phase I closed to accrual as of 11/03/2010)

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• Measurable disease
• No mixed cholangiocarcinoma /hepatocellular carcinoma
• No brain metastases
• No previous systemic chemotherapy regimens for liver cancer
• No previous radiation therapy to the liver or chest
• At least 6 weeks since chemoembolization, radioembolization, or radiofrequency ablation
• More than 4 weeks since biological therapy, hormone therapy, surgery, or open biopsy
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Patients will be assigned to group one or randomly assigned (have an equal chance of being placed) to one of two groups.

Patients in group one will receive sorafenib by mouth twice a day for 4 weeks. They will also receive an infusion of bevacizumab in weeks 1 and 3. Courses may repeat every 4 weeks for as long as benefit is shown.

Patients in group two will receive sorafenib by mouth twice a day for as long as benefit is shown.

Patients will undergo blood sample collection periodically for laboratory studies.

After finishing treatment, patients will be evaluated for 3 years.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

North Central Cancer Treatment Group

Steven Alberts, MD, Protocol chair		Ph: 507-284-4918

Registry Information
Official Title		Phase I/II Randomized Trial of Sorafenib and Bevacizumab as First-Line Therapy in Patients with Locally Advanced or Metastatic Hepatocellular Carcinoma
Trial Start Date		2009-04-10
Trial Completion Date		2010-12-31 (estimated)
Registered in ClinicalTrials.gov		NCT00867321
Date Submitted to PDQ		2009-03-11
Information Last Verified		2011-10-07
NCI Grant/Contract Number		CA25224

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