Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

Rectal Cancer Clinical Trial

Official title:

An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00849394
• Other study ID #: 07-097
• Secondary ID: 122007-001;A07-3
• Status: Completed
• Phase: N/A
• First received: February 20, 2009
• Last updated: October 31, 2012
• Start date: November 2007
• Est. completion date: June 2012

Study information

• Verified date: February 2009
• Source: North Texas Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Colon Cancer
• Rectal Cancer

Locations

Country	Name	City	State
United States	Parkland Health and Hospital System	Dallas	Texas
United States	UT Southwestern Medical Center	Dallas	Texas
United States	VA North Texas Health Care System	Dallas	Texas

Sponsors (2)

Lead Sponsor	Collaborator
North Texas Veterans Healthcare System	University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.		3-6 months	Yes
Secondary	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	Yes