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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
  Purpose

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.


Condition
Colon Cancer
Rectal Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Evaluation of Proteinuria in Patients Receiving Shortened Infusions of Bevacizumab

Resource links provided by NLM:

Drug Information available for: Bevacizumab
U.S. FDA Resources

Further study details as provided by North Texas Veterans Healthcare System:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 106
Study Start Date: November 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Shortened infusions of bevacizumab

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00849394

Locations
United States, Texas
VA North Texas Health Care System
Dallas, Texas, United States, 75216
Parkland Health and Hospital System
Dallas, Texas, United States, 75235
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Sponsors and Collaborators
North Texas Veterans Healthcare System
University of Texas Southwestern Medical Center
Investigators
Principal Investigator: Sachin Shah, Pharm.D. Texas Tech University Health Sciences Center School of Pharmacy
  More Information

No publications provided

Responsible Party: Sachin Shah, Pharm.D., BCOP, Texas Tech University Health Sciences Center School of Pharmacy
ClinicalTrials.gov Identifier: NCT00849394     History of Changes
Other Study ID Numbers: 07-097, 122007-001;, A07-3423
Study First Received: February 20, 2009
Last Updated: October 31, 2012
Health Authority: United States: Federal Government

Keywords provided by North Texas Veterans Healthcare System:
bevacizumab
proteinuria

Additional relevant MeSH terms:
Colonic Neoplasms
Rectal Neoplasms
Proteinuria
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013