Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Pathological Conditions, Signs and Symptoms Proteinuria Rectal Cancer Rectal Diseases Rectal Neoplasms Signs and Symptoms Urination Disorders Urogenital Diseases Urologic Diseases Urological Manifestations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Parkland Health and Hospital System, Dallas, Texas, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.

Time frame: 3-6 months

Secondary outcomes

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.

Time frame: 3-6 months

Sponsors and collaborators

Lead sponsor

North Texas Veterans Healthcare System

Fed

Collaborators

University of Texas Southwestern Medical Center

Registry information

Official study title

An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2012
First posted: Feb 23, 2009
Registry last updated: Nov 1, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed