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Targeted Combination Therapy for Advanced Solid Tumors
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Name of the Trial
Phase I Randomized Study of Sorafenib and Bevacizumab in Patients with Refractory,
Metastatic, or Unresectable Solid Tumors (NCI-05-C-0022). See the protocol
summary .
Principal Investigator
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Dr. Elise Kohn
Principal Investigator |
Dr. Elise Kohn, NCI Center for Cancer Research.
Why This Trial Is Important
Advanced-stage solid tumors are generally difficult to treat with established
forms of therapy. The prognosis for patients with advanced-stage solid tumors
is often relatively poor, not only because their tumors are frequently not amenable
to standard treatments but also because their cancer has likely spread (metastasized)
to other parts of the body.
Solid tumors depend upon new blood vessel formation-a process known as angiogenesis-to
obtain oxygen and nutrients for continued growth. A variety of antiangiogenic
drugs targeting this "Achilles' heel" has been under development for
several years.
An angiogenesis inhibitor called bevacizumab (Avastin®) received FDA approval
in 2004 for the treatment of advanced colorectal cancer. Bevacizumab is a monoclonal
antibody that targets vascular endothelial growth factor (VEGF), a protein
produced
by many types of cancer cells that stimulates new blood vessel growth in tumors.
In this study, researchers are assessing the safety and combined effectiveness
of bevacizumab and a second drug called sorafenib. Sorafenib also inhibits angiogenesis,
but it does so by blocking the activity of proteins that are activated by VEGF
(namely, VEGF receptor proteins). Importantly, the antitumor effects of sorafenib
extend beyond VEGF receptor protein inhibition to include inhibition of other
proteins that may be involved in cancer cell proliferation and tumor growth.
"We hope that the antitumor effects of these two targeted agents will
prove mutually reinforcing when given in combination," said Dr. Kohn.
Who Can Join This Trial
Researcher plan to enroll up to 38 patients aged 18 and older who have been
diagnosed with a solid-tumor malignancy. See the complete
list of eligibility criteria.
Study Site and Contact Information
The trial is taking place at the NIH Clinical Center in Bethesda, Maryland. For more
information about this and other intramural trials, contact the NCI
Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.
Published Results
Posadas EM, Kwitkowski V, Liel MS, et al.: Combinatorial signal transduction inhibition
against vascular endothelial growth factor receptor (VEGFR): early results from a phase I
study of BAY 43-9006 (sorafenib) with bevacizumab in patients with advanced solid tumors.
[Abstract] American Association for Cancer Research: 96th Annual Meeting, April 16-20, 2005,
Anaheim/Orange County, CA. 46: A-LB-213, 2005.
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