Related Links Educational Materials About Clinical Trials Clinical Trials Questions to Ask Your Doctor Drug Information from MedlinePlus

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

Alternate Title

Phase I Randomized Study of Sorafenib and Bevacizumab in Patients With Refractory, Metastatic, or Unresectable Solid Tumors

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase I	Treatment	Closed	18 and over	NCI	NCI-05-C-0022 6750, NCI-6750, NCT00098592

Special Category: NCI Web site featured trial

Trial Description

Purpose:

Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. 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 and bevacizumab may also stop the growth of solid tumors by blocking blood flow to the tumor. Giving sorafenib together with bevacizumab may kill more tumor cells.

This randomized phase I trial is studying the side effects, best dose, and the best way of giving sorafenib together with bevacizumab in treating patients with refractory, metastatic, or unresectable solid tumors.

Eligibility:

Eligibility criteria include the following:

• At least 18 years old
• No squamous cell lung cancer
• At least 4 weeks since biological therapy, chemotherapy, or radiation therapy
• More than 4 weeks since surgery or hormone therapy
• No previous bevacizumab or sorafenib
• 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:

Some patients will receive sorafenib by mouth once a day for 4 weeks or once a day for 5 days in weeks 1-4. They will also receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3. Treatment may repeat every 4 weeks for as long as benefit is shown.

Other patients will be randomly assigned (have an equal chance of being placed in one of two treatment groups).

Patients in group one will receive sorafenib by mouth once a day for 3 weeks during course 1.

Patients in group two will receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3 during course 1.

Beginning in course two, patients in both groups will receive sorafenib by mouth once a day for 3 weeks. They will also receive a 30- to 90-minute infusion of bevacizumab once in weeks 1 and 3. Treatment with sorafenib and bevacizumab may be repeated every 4 weeks for as long as benefit is shown.

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

NCI - Center for Cancer Research

Elise Kohn, MD, Principal investigator		Ph: 301-402-2726

Related Information

Featured trial article

Registry Information
Official Title		A Phase I Trial of BAY 43-9006 (Sorafenib) and Bevacizumab in Refractory Solid Tumors With Biologic and Proteomic Analysis
Trial Start Date		2004-12-20
Trial Completion Date		2007-07-08 (estimated)
Registered in ClinicalTrials.gov		NCT00098592
Date Submitted to PDQ		2004-10-22
Information Last Verified		2008-04-06

Back to Top