Cancer Clinical Trial - Bevacizumab (Avastin) Induced Hypertension &

Status Terminated

Clinical Trial Summary

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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00322725
Study type	Observational
Source	University of New Mexico
Contact
Status	Terminated
Phase
Start date	February 2006
Completion date	April 2009

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Bevacizumab (Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms