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

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

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).

Study Overview

• Status: Terminated
• Conditions: Malignant Neoplasm
• Intervention / Treatment: Other: Questionnaire Administration; Procedure: Biospecimen Collection

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.

• Study Type: Observational
• Enrollment (Actual): 55

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

MDACC Cancer Participants

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ancillary-correlative (biospecimen collection); 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.	Other: Questionnaire Administration; Ancillary studies; Procedure: Biospecimen Collection; Undergo collection of blood

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Elie Mouhayar, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): September 12, 2007
• Primary Completion (Actual): May 2, 2018
• Study Completion (Actual): May 2, 2018

Study Registration Dates

• First Submitted: September 18, 2007
• First Submitted That Met QC Criteria: September 18, 2007
• First Posted (Estimate): September 19, 2007

Study Record Updates

• Last Update Posted (Actual): January 22, 2020
• Last Update Submitted That Met QC Criteria: January 17, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Wounds and Injuries; Drug-Related Side Effects and Adverse Reactions; Radiation Injuries; Neoplasms; Cardiotoxicity
• Other Study ID Numbers: 2006-0921 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-02471 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No