Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of kidney cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with unresectable or metastatic kidney cancer.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma|
- Progression Free Survival (PFS) When Bevacizumab is Administered to Patients With Unresectable and/or Metastatic Papillary Renal Cell Carcinoma. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Progression was defined by using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
- Response Rate to Bevacizumab in This Population. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response, Disappearance of all target lesions; Partial Response, >=30% decrease in the sum of the longest diameter of target lesions; Progressive Disease, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Stable Disease, neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
- Safety of Bevacizumab in This Population of Patients [ Time Frame: Up to 2 years ] [ Designated as safety issue: Yes ]Grade 3 or higher toxicities according to CTCAE version 3.0
|Study Start Date:||February 2008|
|Study Completion Date:||May 2013|
|Primary Completion Date:||August 2011 (Final data collection date for primary outcome measure)|
15 mg/kg over 90 minutes
15 mg/kg over 90 minutes every 3 weeks
Other Name: Avastin
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00601926
|United States, Ohio|
|Ohio State University Medical Center|
|Columbus, Ohio, United States, 43210|
|Principal Investigator:||Paul Monk, MD||Ohio State University|