Full Text View
Tabular View
No Study Results Posted
Related Studies
Bevacizumab (Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review
The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2009 by University of New Mexico.   Recruitment status was  Active, not recruiting
Study NCT00322725   Information provided by University of New Mexico

First Received on May 5, 2006.   Last Updated on June 23, 2010   History of Changes

May 5, 2006
June 23, 2010
February 2006
December 2010   (final data collection date for primary outcome measure)
 
 
Complete list of historical versions of study NCT00322725 on ClinicalTrials.gov Archive Site
 
 
 
Bevacizumab (Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review
Bevacizumab(Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review

1.11 Retrospectively evaluate for a correlation between tumor response and changes in systolic/diastolic/mean arterial blood pressures in patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies.

1.12 Retrospectively evaluate for differences in tumor response between patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies.

1.21 Determine if there were differences in bevacizumab induced hypertension rates between different tumor types.

1.22 Evaluate for differences in bevacizumab induced hypertension rates between males and females.

1.23 Examine if there were associations between a particular chemotherapeutic agent(s), that may have had an increased propensity of inducing hypertension when combined with bevacizumab.

This study is a retrospective chart review of all patients with metastatic cancer of any type treated with bevacizumab(with or without chemotherapy) at the University of New Mexico Cancer Research & Treatment Center within the last year to investigate if there is a correlation between bevacizumab induced hypertension and response rates. We will look at a wide variety of tumor types with a planned subset analysis to evaluate these correlations within individual tumor types. As mentioned above, Grades of bevacizumab induced hypertension is typically reported according to the NCI common terminology criteria for adverse events which will be included in our study but in addition we will also evaluate for incremental changes in systolic(SBP), diastolic (DBP), and mean arterial blood(MAP) pressures in mmHg. Looking at these three variables will allow us to see if there is one component (SBP or DBP) or a combination of both (MAP) that may allow us to predict response. Response will be measured by appropriate radiographic imagine (CT scan or x-rays) and/or appropriate tumor markers. In addition, as VEGF appears to play a role in hypertension, we would like to look at pre-existing hypertension as a predictor for response and/or bevacizumab induced hypertension.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
 
Non-Probability Sample

Patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies.

Patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies.

Cancer
 
 
 

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
February 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients treated with bevacizumab, with or without chemotherapy, with a wide variety of metastatic malignancies.
  • Patients with and without pre-existing hypertension treated with bevacizumab plus or minus chemotherapy with a wide variety of metastatic malignancies.

Exclusion Criteria:

  • Not specified.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00322725
INST 0604C
Yes
Fa-Chyi Lee, MD; Principal Investigator, University of New Mexico - CRTC
University of New Mexico
 
Principal Investigator: Fa-Chyi Lee, MD University of New Mexico
University of New Mexico
July 2009

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