Targeted Treatment for Advanced Solid Tumors
Name of the Trial
Phase I Partially Randomized Study of Dasatinib and Bevacizumab in Patients with Metastatic or Unresectable Solid Tumors. See the protocol summary at http://www.cancer.gov/clinicaltrials/NCI-09-C-0019.
Dr. Elise Kohn, NCI Center for Cancer Research
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 of 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 tumors, 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 http://www.cancer.gov/clinicaltrials/NCI-09-C-0019 or call the NCI's Clinical Trials Referral Office at 1-888-NCI-1937. The toll-free call is confidential.
An archive of "Featured Clinical Trial" columns is available at http://www.cancer.gov/clinicaltrials/ft-all-featured-trials.