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Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00532064
First Posted: September 19, 2007
Last Update Posted: April 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
  Purpose

Primary Objective:

-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 Objective:

-To prospectively evaluate the incidence and severity of cardiac toxicity related to sunitinib or sorafenib during chemotherapy.


Condition Intervention
Advanced Cancers Behavioral: Questionnaire

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Sensitivity of biomarkers for detecting cardiotoxicity [ Time Frame: Monthly ]
    The BNP and Troponin reassessed at 2 weeks and then each time blood is obtained for safety purposes during chemotherapy (approximately every 4-6 weeks); then data used 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.


Biospecimen Retention:   Samples With DNA
During the standard-of-care blood draws, additional blood will be drawn to test troponin I and/or T and BNP levels.

Estimated Enrollment: 200
Actual Study Start Date: September 2007
Estimated Study Completion Date: September 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Early Cardiotoxicity Detection
Patients with advanced cancer receiving sunitinib malate or sorafenib chemotherapy.
Behavioral: Questionnaire
Symptom questionnaire taking about 10-15 minutes.
Other Name: Survey

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with advanced cancer receiving sunitinib malate or sorafenib chemotherapy.
Criteria

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
  • LVEF less than 40%
  • Decompensated HF in the last 3 months
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00532064


Locations
United States, Texas
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Elie Mouhayar, MD M.D. Anderson Cancer Center
  More Information

Additional Information:
Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00532064     History of Changes
Other Study ID Numbers: 2006-0921
First Submitted: September 18, 2007
First Posted: September 19, 2007
Last Update Posted: April 13, 2017
Last Verified: April 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancers
Cardiotoxicity Detection
Heart Damage
Troponin 1 Blood Test
B-type Natriuretic Peptide Blood Test
Questionnaire
Survey
BNP

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Sorafenib
Sunitinib
Antineoplastic Agents
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors