Cardiac Biomarkers in Early Detection of Cardiotoxicity in Patients Receiving Sunitinib or Sorafenib Chemotherapy

Study Overview
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Brief Summary
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This trial studies how well cardiac biomarkers work in the early detection of cardiotoxicity in patients receiving sunitinib malate or sorafenib chemotherapy. Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Testing for cardiac biomarkers, such as troponin I and/or T and B-type natriuretic peptide (BNP), may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram).

Detailed Description
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PRIMARY OBJECTIVES: I. To determine if specific biomarkers (troponin I and B-type natriuretic peptide [BNP]) detect cardiotoxicity earlier than standard clinical means in patients receiving sunitinib malate (SU11248) or sorafenib chemotherapy. SECONDARY OBJECTIVES: I. To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy. OUTLINE: Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP.

Official Title
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Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers

Conditions
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Malignant Neoplasm

Intervention / Treatment
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* Procedure: Biospecimen Collection
* Other: Questionnaire Administration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient age 18-85 years Starting a new course of chemotherapy at MD Anderson Cancer Center that includes sunitinib or sorafenib Has a life expectancy of greater than 6 months Exclusion Criteria: Unstable angina within the last 3 months Myocardial infarction within the last 3 months Left ventricular ejection fraction (LVEF) less than 40% Decompensated heart failure (HF) in the last 3 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ancillary-correlative (biospecimen collection)<br>Patients receive sunitinib malate or sorafenib chemotherapy then undergo blood collection 2 weeks later, and then every 4-6 weeks for up to 6 months to test for troponin I and BNP. | Procedure: Biospecimen Collection<br>* Undergo collection of blood<br>Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of each biomarker for detecting cardiotoxicity | Will estimate with exact 95% confidence intervals. | Up to 6 months | 
| Specificity of each biomarker for detecting cardiotoxicity | Will estimate with exact 95% confidence intervals. | Up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of cardiotoxicity | Will use the methods of Gooley, et al (1999) to estimate the cumulative incidence of cardiotoxicity while considering deaths from other causes as a competing risk. Will estimate the cumulative incidence of cardiotoxicity while stratifying by common risk factors (one at a time). Will use mixed linear models to model the biomarker levels over time, accounting for the correlation between biomarker levels within patient. Will use logistic regression to model the log odds of cardiotoxicity as a function of common risk factors for cardiotoxicity. Will also include the duration of chemotherapy use and the MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score as a potential prognostic factor for cardiotoxicity. | Up to 6 months | 
| MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score | Will summarize the MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score over time with descriptive statistics and boxplots. | Up to 6 months |