Trial record 1 of 1 for:    NCT01032278
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Studying Biomarkers in Detecting Heart Damage in Patients Receiving Chemotherapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01032278
First received: December 13, 2009
Last updated: May 22, 2013
Last verified: May 2013
  Purpose

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.


Condition Intervention
Cardiac Toxicity
Unspecified Adult Solid Tumor, Protocol Specific
Drug: Systemic chemotherapy
Other: Laboratory biomarker analysis
Other: Questionnaire administration

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Sensitivity and specificity of cardiac biomarkers in detecting cardiotoxicity within 12 months of initiation of anthracycline-based chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity of serial LVEF measurements in detecting cardiotoxicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Clinical management and outcomes of patients with abnormal cardiac biomarkers or clinically defined cardiotoxicity during chemotherapy [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Supportive utility of patient-reported symptoms for the development of cardiac-related toxicity [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 830
Study Start Date: January 2011
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Biomarker Testing
Biomarker testing of participants undergoing anthracycline-based chemotherapy
Drug: Systemic chemotherapy Other: Laboratory biomarker analysis
Other Name: Biomarker Testing
Other: Questionnaire administration
Other Names:
  • Survey
  • Questionnaire

Detailed Description:

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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01032278

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01032278     History of Changes
Other Study ID Numbers: CDR0000660615, MDA-2007-0914A, CDR0000660615
Study First Received: December 13, 2009
Last Updated: May 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
cardiac toxicity
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on April 17, 2014