A Phase II Trial of Gemcitabine, Capecitabine, and Bevacizumab in Metastatic Renal Cell Carcinoma
- to determine the objective response rate and estimate the time to progression of
combination gemcitabine, capecitabine, and bevacizumab in patients with metastatic
clear cell renal cell cancer;
- to determine survival of combination gemcitabine, capecitabine, and bevacizumab in
patients with metastatic cell renal cell cancer;
- to determine the toxicity of combination gemcitabine, capecitabine, and bevacizumab in
patients with metastatic renal cell cancer;
- to collect baseline serum and plasma samples for exploration of possible prognostic and
predictive markers
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Objective Response Rate
Per RECIST Criteria (V1.0) using standard cross-sectional CT scanning: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Response (R)= CR + PR.
12 weeks
No
Walter Stadler, MD
Principal Investigator
University of Chicago
United States: Food and Drug Administration
13662A
NCT00523640
March 2005
April 2011
Name | Location |
---|---|
University of Chicago | Chicago, Illinois 60637 |