Malignant Neoplasm
Conditions
Brief summary
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
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.
Interventions
PROCEDUREBiospecimen Collection
Undergo collection of blood
OTHERQuestionnaire Administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Specificity of each biomarker for detecting cardiotoxicity | Up to 6 months | Will estimate with exact 95% confidence intervals. |
| Sensitivity of each biomarker for detecting cardiotoxicity | Up to 6 months | Will estimate with exact 95% confidence intervals. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of cardiotoxicity | Up to 6 months | 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. |
| MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score | Up to 6 months | Will summarize the MD Anderson Symptom Inventory - Heart Failure (MDASI-HF) score over time with descriptive statistics and boxplots. |
Countries
United States
Outcome results
None listed