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Clinical Trial Summary

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.


Clinical Trial Description

- 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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00556205
Study type Interventional
Source Massachusetts General Hospital
Contact
Status Withdrawn
Phase Phase 2
Start date September 2009
Completion date September 2009

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