A Prospective Study Evaluating Complications and Clinical Response in Cancer Patients Treated With Anti-VEGF-Related Therapies
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
Study Overview
Brief Summary
This study collects information about complications and clinical response in cancer patients treated with anti-VEGF-related therapies. This study aims to observe side effects that may happen to patients with advanced cancer who are treated with anti-VEGF related therapy. This may help doctors learn if there are any relationships between these side effects and how the disease may respond to treatment.
Detailed Description
PRIMARY OBJECTIVE:
I. To explore the incidence of clinical complications associated with anti-VEGF-related therapies in cancer patients treated at Emory University and the University of Texas M.D. Anderson Cancer Center (MDACC).
SECONDARY OBJECTIVES:
I. To explore the correlation of clinical response rates to a novel blood pressure scoring system in cancer patients treated with anti-VEGF-related therapies.
II. To explore the correlation of objective response to each toxicity grade 3 or higher in cancer patients treated with anti-VEGF-related therapies.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Other
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients must be able to understand and be willing to sign a written informed consent document
- •Patients must be receiving any anti-VEGF-related regimen in monotherapy or combination therapy
Exclusion Criteria
- Not provided
Arms & Interventions
Observational (medical records review)
Patients' medical records are reviewed.
Intervention: Electronic Health Record Review (Other)
Outcomes
Primary Outcomes
Incidence of grade 3+ adverse events (AE) at least possibly related to anti-VEGF-related treatment (overall and each type separately)
Time Frame: Up to 5 years
For each toxicity, will estimate the odds ratio, associated 95% confidence interval and p-value.
Secondary Outcomes
No secondary outcomes reported