Evaluation of Protein in the Urine in Patients Receiving Bevacizumab

NCT00849394 | Completed

• 3 other identifiers: 07-097122007-001;A07-3423
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Colon Cancer; Rectal Cancer

Keywords

bevacizumab; proteinuria

Outcome Measures

Primary Outcomes (1)

• To evaluate the effect of shortened infusions (0.5 mg/kg/min) of bevacizumab on the incidence of proteinuria.

  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.

  3-6 months

Study Arms (1)

1

Shortened infusions of bevacizumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients must be 18 years older
• Patients must be receiving his/her first dose of bevacizumab
• Patients must sign an informed consent

You may not qualify if:

• Patients receiving \> 10 mg/kg doses of bevacizumab

Sponsors & Collaborators

• North Texas Veterans Healthcare System: lead
• University of Texas Southwestern Medical Center: collaborator

Study Sites (3)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Parkland Health and Hospital System

Dallas, Texas, 75235, United States

Location

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Rectal Neoplasms; Proteinuria

Condition Hierarchy (Ancestors)

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; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sachin Shah, Pharm.D.

  Texas Tech University Health Sciences Center School of Pharmacy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED

Study Record Dates

• First Submitted: February 20, 2009
• First Posted: February 23, 2009
• Study Start: November 1, 2007
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: November 1, 2012

Record last verified: 2009-02

Locations

US (3)