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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:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00532064
First received: September 18, 2007
Last updated: March 31, 2014
Last verified: March 2014
  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 ] [ Designated as safety issue: No ]
    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
Study Start Date: September 2007
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00532064

Locations
United States, Texas
UT 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:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00532064     History of Changes
Other Study ID Numbers: 2006-0921
Study First Received: September 18, 2007
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

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:
Sorafenib
Sunitinib
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Antineoplastic Agents
Enzyme Inhibitors
Growth Inhibitors
Growth Substances
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protein Kinase Inhibitors
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014