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

M.D. Anderson Cancer Center

Status: Terminated

Conditions: Malignant Neoplasm

Treatments: Other: Questionnaire Administration; Procedure: Biospecimen Collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00532064

P30CA016672 (U.S. NIH Grant/Contract)

2006-0921 (Other Identifier)

NCI-2018-02471 (Registry Identifier)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 55 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

55 participants in 1 patient group

Ancillary-correlative (biospecimen collection)

Description:

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.

Treatment:

Procedure: Biospecimen Collection

Other: Questionnaire Administration