Know Cancer

or
forgot password

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


N/A
18 Years
85 Years
Open (Enrolling)
Both
Cardiac Toxicity, Unspecified Adult Solid Tumor, Protocol Specific

Thank you

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 TexasHouston, Texas  77030-4009