A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment
18 Years
85 Years
Both
Cardiac Toxicity, Unspecified Adult Solid Tumor, Protocol Specific
Trial Information
A Multi-Center Study in Patients Undergoing Anthracycline-Based Chemotherapy to Assess the Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment
OBJECTIVES:
Primary
- To assess the sensitivity and specificity of cardiac biomarkers, specifically B-type
natriuretic peptide (BNP) and troponin I, in detecting cardiotoxicity in patients
undergoing anthracycline-based chemotherapy.
Secondary
- To define the sensitivity and specificity of serial LVEF measurements in detecting
cardiotoxicity.
- To describe the clinical management and outcomes of patients identified with abnormal
cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy.
- To confirm the supportive utility of patient-reported symptoms for the development of
cardiac-related toxicity.
OUTLINE: This is a multicenter study.
Patients receive anthracycline-based chemotherapy for approximately 8 courses.
Patients undergo physical exam, ECHO, EKG, and laboratory assessments, including measurement
of B-type natriuretic peptide (BNP) and troponin I biomarkers, at baseline and periodically
for up to 12 months. Patients also complete the M.D. Anderson Symptom Index-Heart Failure
questionnaire at baseline and periodically for up to 12 months. Patients with an identified
cardiac event, suspected cardiotoxicity, or abnormal biomarkers are referred to a
cardiologist for treatment.
After completion of chemotherapy, patients are followed up at 6 and 12 months.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Planning to start a new course of chemotherapy that includes an anthracycline
- Does not have to be first-line therapy
- B-type natriuretic peptide (BNP) < 200 pg/mL
- Troponin I < 0.4 ng/mL
PATIENT CHARACTERISTICS:
- Life expectancy > 12 months
- Left ventricular ejection fraction (LVEF) ≥ 50%
- No unstable angina within the past 3 months
- No myocardial infarction within the past 3 months
- No decompensated heart failure within the past 3 months
- No pre-existing or prior symptomatic arrhythmia within the past 3 months
- No severe pulmonary disease (FEV ≤ 1.0 L)
- No pulmonary hypertension (mean pulmonary artery pressure ≥ 60 mm Hg)
- Not dependent on oxygen
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
- Prior anthracyclines allowed
- No concurrent dexrazoxane
Type of Study:
Interventional
Study Design:
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Sensitivity and specificity of cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy
Outcome Time Frame:
12 months
Safety Issue:
No
Principal Investigator
Michael J. Fisch, MD, MPH, FACP
Investigator Role:
Study Chair
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000660615
NCT ID:
NCT01032278
Start Date:
January 2011
Completion Date:
Related Keywords:
- Cardiac Toxicity
- Unspecified Adult Solid Tumor, Protocol Specific
- cardiac toxicity
- unspecified adult solid tumor, protocol specific
Name | Location |
|---|---|
| M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
