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| Tracking Information | |||||
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| First Received Date ICMJE | May 5, 2006 | ||||
| Last Updated Date | June 23, 2010 | ||||
| Start Date ICMJE | February 2006 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00322725 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Bevacizumab (Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review | ||||
| Official Title ICMJE | Bevacizumab(Avastin) Induced Hypertension and Correlation With Tumor Response, a Chart Review | ||||
| Brief 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. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
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| Biospecimen | |||||
| 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. |
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| Condition ICMJE | Cancer | ||||
| Intervention ICMJE | |||||
| Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 25 | ||||
| Estimated Completion Date | February 2011 | ||||
| Estimated Primary Completion Date | December 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00322725 | ||||
| Other Study ID Numbers ICMJE | INST 0604C | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Fa-Chyi Lee, MD; Principal Investigator, University of New Mexico - CRTC | ||||
| Study Sponsor ICMJE | University of New Mexico | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of New Mexico | ||||
| Verification Date | July 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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