Rectal Cancer Clinical Trial
Official title:
An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab
Verified date | February 2009 |
Source | North Texas Veterans Healthcare System |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Federal Government |
Study type | Observational |
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.
Status | Completed |
Enrollment | 106 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Parkland Health and Hospital System | Dallas | Texas |
United States | UT Southwestern Medical Center | Dallas | Texas |
United States | VA North Texas Health Care System | Dallas | Texas |
Lead Sponsor | Collaborator |
---|---|
North Texas Veterans Healthcare System | University of Texas Southwestern Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria. | 3-6 months | Yes | |
Secondary | 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 | Yes |
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