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Targeted Treatment for Advanced Solid Tumors
Untitled Document
Name of the Trial
Phase I Partially Randomized Study of Dasatinib and Bevacizumab in Patients
with Metastatic or Unresectable Solid Tumors (NCI-09-C-0019). See the protocol
summary.
Principal Investigator
Dr. Elise Kohn, NCI Center for Cancer Research
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Dr. Elise Kohn
Principal Investigator |
Why This Trial Is Important
The prognosis for patients with advanced-stage solid tumors is often poor.
Not only are their tumors frequently recurrent and no longer responsive to standard
treatments, but their cancer also has likely spread (metastasized) to other
parts of the body.
Solid tumors depend on new blood vessel formation-a process known as angiogenesis-to
obtain oxygen and nutrients for continued growth. A variety of drugs designed
to inhibit tumor blood vessel formation, called angiogenesis inhibitors, have
been developed for the treatment for many tumor types.
An angiogenesis inhibitor called bevacizumab
(Avastin) is approved for the treatment of several solid tumors. In earlier
trials, NCI researchers tested the combination of bevacizumab with another targeted
drug called sorafenib.
In those trials, "we saw a surprising frequency of
partial responses,
and also prolonged disease stabilization," especially in patients with
ovarian cancer, said Dr. Kohn. However, patients experienced a large number
of side effects with that drug combination, most likely because both drugs target
the same cell signaling pathway involved in blood vessel formation.
The researchers designed the current trial to use the drug dasatinib
instead of sorafenib. They believe that the combination of bevacizumab and dasatinib
may have fewer side effects, since the two drugs target different cell signaling
pathways. "We think we'll get less interactive toxicity, but similar antitumor
activity," explained Dr. Kohn.
The researchers plan to enroll 48 patients with ovarian cancer, renal cell
cancer, gastrointestinal stromal tumor, melanoma, or other solid tumors that
cannot be removed surgically or have metastasized and that have not responded
to standard treatment.
For More Information
See the lists of entry
criteria and trial contact information at or call the NCI's Clinical Trials
Referral Office at 1-888-NCI-1937. The toll-free call is confidential.
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