NCT00601926

Bevacizumab in Treating Patients With Unresectable or Metastatic Kidney Cancer

A Phase II Trial Of Avastin (Bevacizumab) In Patients With Metastatic Papillary Renal Cell Carcinoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Paul Monk · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Kidney Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	15 mg/kg over 90 minutes every 3 weeks

Timeline

• Start date: 2008-02-01
• Primary completion: 2011-08-01
• Completion: 2013-05-01
• First posted: 2008-01-28
• Last updated: 2015-06-15
• Results posted: 2015-02-18

Locations

1 site across 1 country: United States