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Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00849394
Enrollment
106
Registered
2009-02-23
Start date
2007-11-30
Completion date
2012-06-30
Last updated
2012-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon Cancer, Rectal Cancer

Keywords

bevacizumab, proteinuria

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.

Interventions

None listed

Sponsors

University of Texas Southwestern Medical Center
CollaboratorOTHER
North Texas Veterans Healthcare System
Lead SponsorFED

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026