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Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

NCT ID: NCT00849394

Last Updated: 2012-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-11-30

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Colon Cancer Rectal Cancer

Keywords

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bevacizumab proteinuria

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Shortened infusions of bevacizumab

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role collaborator

North Texas Veterans Healthcare System

FED

Sponsor Role lead

Responsible Party

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Texas Tech University Health Sciences Center School of Pharmacy

Principal Investigators

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Sachin Shah, Pharm.D.

Role: PRINCIPAL_INVESTIGATOR

Texas Tech University Health Sciences Center School of Pharmacy

Locations

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VA North Texas Health Care System

Dallas, Texas, United States

Site Status

Parkland Health and Hospital System

Dallas, Texas, United States

Site Status

UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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122007-001;

Identifier Type: -

Identifier Source: secondary_id

A07-3423

Identifier Type: -

Identifier Source: secondary_id

07-097

Identifier Type: -

Identifier Source: org_study_id