Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

Completed

• Conditions: Colon Cancer; Rectal Cancer

• Registration Number: NCT00849394
• Lead Sponsor: North Texas Veterans Healthcare System

Brief Summary

This is a clinical research study to look at the incidence of proteinuria (a condition in which urine contains an abnormal amount of protein) caused by shortened infusions (given into the vein over 10 or 15 minutes) of bevacizumab (a medication prescribed for colon, lung, or breast cancer). There are currently no published studies or clinical data looking at how safe shortened infusions of bevacizumab are in relationship to the side effect of proteinuria. We hypothesis that shortened infusions of bevacizumab will result in an increased risk for proteinuria compared to the standard infusions of this agent.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Status Verified: 2009-02
• Study First Submitted: 2009-02-20
• Study First Submitted QC: 2009-02-20
• Study First Posted: 2009-02-23
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-10-31
• Last Update Posted: 2012-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

Inclusion Criteria

• Patients must be 18 years older
• Patients must be receiving his/her first dose of bevacizumab
• Patients must sign an informed consent

Exclusion Criteria

• Patients receiving > 10 mg/kg doses of bevacizumab

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.	3-6 months

Secondary Outcome Measures

Name	Time	Method
To evaluate the time (number of days) to the incidence of proteinuria with shortened infusions of bevacizumab AND to evaluate the effect of controlled versus uncontrolled hypertension and the incidence of proteinuria.	3-6 months

Trial Locations

Locations (3)

VA North Texas Health Care System; 🇺🇸 Dallas, Texas, United States

Parkland Health and Hospital System; 🇺🇸 Dallas, Texas, United States

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States