Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers - Full Text View

Sponsored by:	M.D. Anderson Cancer Center
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00532064

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

MedlinePlus related topics: Cancer

Drug Information available for: Sunitinib Sunitinib malate Sorafenib Sorafenib tosylate Nesiritide

U.S. FDA Resources

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

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

Primary Outcome Measures:

To try to detect heart damage during chemotherapy, before the heart muscle weakens, by using blood tests called troponin 1 and B-type natriuretic peptide (BNP). [ Time Frame: 2 Years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

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 Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
1 Patients with advanced cancer receiving sunitinib malate or sorafenib chemotherapy.	Behavioral: Questionnaire Symptom questionnaire taking about 10-15 minutes.

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

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

Contacts

Contact: Daniel J. Lenihan, MD

713-794-4197

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Daniel J. Lenihan, MD

Sponsors and Collaborators

M.D. Anderson Cancer Center

Investigators

Principal Investigator:

Daniel J. Lenihan, MD

U.T.M.D. Anderson Cancer Center

More Information

MD Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Daniel J. Lenihan, MD/Associate Professor )
Study ID Numbers:	2006-0921
Study First Received:	September 18, 2007
Last Updated:	December 30, 2008
ClinicalTrials.gov Identifier:	NCT00532064
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

Study placed in the following topic categories:

Natriuretic Peptide, Brain
Sunitinib
Sorafenib

ClinicalTrials.gov processed this record on January 16, 2009