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CompletedNCT00849394Updated Nov 1, 2012

Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

An observational study in Colon Cancer and Rectal Cancer, sponsored by North Texas Veterans Healthcare System. Completed at 3 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2012-11-01.

Sponsored by North Texas Veterans Healthcare System · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Colon Cancer
  • Rectal Cancer

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Keywords

  • bevacizumab
  • proteinuria
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In context

Proteinuria

234 studies on the registry are indexed under Proteinuria; 43 are open to participants now.

This study's enrollment of 106 is below the median of 125 across 53 observational studies indexed under Proteinuria.

Browse Proteinuria studies →

Lead sponsor

North Texas Veterans Healthcare System is the lead sponsor of 31 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

106 patients receiving bevacizumab doses of \< 10 mg/kg at a rate of 0.5 mg/kg/min in hematology/oncology outpatient clinic. Most of the patients are likely to have advanced stage colon or rectal cancer.

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

Exclusion Criteria:

  • Patients receiving > 10 mg/kg doses of bevacizumab
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (actual)

Groups and cohorts

  • 1

    Shortened infusions of bevacizumab

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What researchers measure

Primary outcomes

  1. 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

  1. 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

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Study locations

3 sites
  • VA North Texas Health Care System
    Dallas, Texas 75216, United States
  • Parkland Health and Hospital System
    Dallas, Texas 75235, United States
  • UT Southwestern Medical Center
    Dallas, Texas 75390, United States
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 1, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00849394
Lead sponsor
North Texas Veterans Healthcare System
Collaborators
University of Texas Southwestern Medical Center
First posted
Feb 23, 2009
Start date
Nov 2007
Primary completion
Jun 2012
Completion
Jun 2012
Last update
Nov 1, 2012

Study contacts

Sachin Shah, Pharm.D.
principal investigator · Texas Tech University Health Sciences Center School of Pharmacy

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2009. You cannot join it, but the record below documents what was studied.

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