Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00322725
Status:
TERMINATED
Last Update Posted:
2024-01-11
First Post:
2006-05-05
Brief Title:
Bevacizumab Avastin Induced Hypertension and Correlation With Tumor Response a Chart Review
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
BevacizumabAvastin Induced Hypertension and Correlation With Tumor Response a Chart Review
Status:
TERMINATED
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
This is a chart review only and not a clinical trial This was inadvertently entered in the system
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
111 Retrospectively evaluate for a correlation between tumor response and changes in systolicdiastolicmean arterial blood pressures in patients treated with bevacizumab with or without chemotherapy with a wide variety of metastatic malignancies
112 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
121 Determine if there were differences in bevacizumab induced hypertension rates between different tumor types
122 Evaluate for differences in bevacizumab induced hypertension rates between males and females
123 Examine if there were associations between a particular chemotherapeutic agents that may have had an increased propensity of inducing hypertension when combined with bevacizumab
112 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
121 Determine if there were differences in bevacizumab induced hypertension rates between different tumor types
122 Evaluate for differences in bevacizumab induced hypertension rates between males and females
123 Examine if there were associations between a particular chemotherapeutic agents that may have had an increased propensity of inducing hypertension when combined with bevacizumab
Detailed Description:
This study is a retrospective chart review of all patients with metastatic cancer of any type treated with bevacizumabwith 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 systolicSBP diastolic DBP and mean arterial bloodMAP 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 andor 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 andor bevacizumab induced hypertension
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None