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Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

This study has been completed.
Sponsor:
Collaborator:
University of Texas Southwestern Medical Center
Information provided by:
North Texas Veterans Healthcare System
ClinicalTrials.gov Identifier:
NCT00849394
First received: February 20, 2009
Last updated: October 31, 2012
Last verified: February 2009
History of Changes

February 20, 2009
October 31, 2012
November 2007
June 2012   (final data collection date for primary outcome measure)
To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria. [ Time Frame: 3-6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00849394 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Same as current
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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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.
  • Colon Cancer
  • Rectal Cancer
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1
Shortened infusions of bevacizumab
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
106
June 2012
June 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00849394
07-097, 122007-001;, A07-3423
No
Sachin Shah, Pharm.D., BCOP, Texas Tech University Health Sciences Center School of Pharmacy
North Texas Veterans Healthcare System
University of Texas Southwestern Medical Center
Principal Investigator: Sachin Shah, Pharm.D. Texas Tech University Health Sciences Center School of Pharmacy
North Texas Veterans Healthcare System
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP