Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

RATIONALE: Studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors identify and learn more about biomarkers related to heart damage due to chemotherapy. It may also help doctors plan the best treatment.

PURPOSE: This clinical trial is studying how well biomarkers work in detecting heart damage in patients receiving chemotherapy.

Further Study Information

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.

Eligibility 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

Trial Contact Information

Trial Lead Organizations/Sponsors

M. D. Anderson Cancer Center at University of Texas

Michael J. Fisch

Study Chair

U.S.A.
Texas
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center	Ph: 713-792-3245

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01032278
Information obtained from ClinicalTrials.gov on November 20, 2012

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