Renal Cell Carcinoma Clinical Trial
Official title:
Phase II, Randomized Trial of Bevacizumab With or Without Sunitinib in Sunitinib-Refractory Patients With Metastatic Renal Cell Carcinoma
The purpose of this research study is to further define an effective strategy for people with renal cell carcinoma and to learn the safety and effectiveness of two different types of sunitinib-refractory treatments: Bevacizumab alone or a combination of sunitinib and bevacizumab. Sunitinib is an FDA approved drug and is currently one of the standard treatments for advanced renal cell carcinoma. However, some people who receive this treatment do not respond to treatment or they stop responding to treatment. Bevacizumab is an FDA approved drug used for the treatment of several cancers however, is not yet approved for use in renal cell carcinoma.
- Participants will receive one of two treatment possibilities. Since no one knows which
of the study options is best, participants will be "randomized" to one fo the three
treatment groups.
- Group 1 will stop their current treatment with sunitinib and receive a dose of
bevacizumab once every 2 weeks. Group 2 will receive the standard treatment of
sunitinib with the addition of bevacizumab.
- All study participants will undergo the same study procedures. These study procedures
will include the following at intervals specified in the protocol: medical history
review; vital signs; physical exam; urine analysis; EKG and CT scan.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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