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
Sponsor:
Information provided by:
University of New Mexico
ClinicalTrials.gov Identifier:
NCT00322725
First received: May 5, 2006
Last updated: June 23, 2010
Last verified: July 2009
  Purpose

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.


Condition
Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Bevacizumab(Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review

Resource links provided by NLM:


Further study details as provided by University of New Mexico:

Estimated Enrollment: 25
Study Start Date: February 2006
Estimated Study Completion Date: February 2011
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00322725

Locations
United States, New Mexico
University of New Mexico
Albuquerque, New Mexico, United States, 87131
Sponsors and Collaborators
University of New Mexico
Investigators
Principal Investigator: Fa-Chyi Lee, MD University of New Mexico
  More Information

No publications provided

Responsible Party: Fa-Chyi Lee, MD; Principal Investigator, University of New Mexico - CRTC
ClinicalTrials.gov Identifier: NCT00322725     History of Changes
Other Study ID Numbers: INST 0604C
Study First Received: May 5, 2006
Last Updated: June 23, 2010
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
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 July 23, 2014