A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma
OBJECTIVES:
Primary
- To evaluate the progression-free survival when bevacizumab is administered to patients
with unresectable and/or metastatic papillary renal cell carcinoma.
- To further evaluate the safety of bevacizumab in these patients.
Secondary
- To examine, in a preliminary manner, the response rate to bevacizumab in these
patients.
- To collect and store blood and urine samples for future analysis.
- To evaluate overall survival when bevacizumab is administered to these patients.
OUTLINE: Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats
every 3 weeks in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months for 1 year and
then every 6 months for 3 years.
Interventional
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Evaluate progression free survival (PFS) when Bevacizumab is administered to patients with unresectable and/or metastatic papillary renal cell carcinoma.
Up to 2 years
No
J. Paul Monk, MD
Principal Investigator
Ohio State University
United States: Food and Drug Administration
OSU-06111
NCT00601926
February 2008
Name | Location |
---|---|
Ohio State University Medical Center | Columbus, Ohio 43210 |