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

Malignant Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00532064
• Other study ID #: 2006-0921
• Secondary ID: NCI-2018-0247120
• Status: Terminated
• Start date: September 12, 2007
• Est. completion date: May 2, 2018

Study information

• Verified date: January 2020
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 55
• Est. completion date: May 2, 2018
• Est. primary completion date: May 2, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiotoxicity
• Malignant Neoplasm
• Neoplasms

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood

Other:
• Questionnaire Administration
Ancillary studies

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity of each biomarker for detecting cardiotoxicity	Will estimate with exact 95% confidence intervals.	Up to 6 months
Primary	Specificity of each biomarker for detecting cardiotoxicity	Will estimate with exact 95% confidence intervals.	Up to 6 months
Secondary	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
Secondary	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

External Links

•   MD Anderson Cancer Center Website