Overview

This trial is active, not recruiting.

Condition advanced cancers
Treatment questionnaire
Sponsor M.D. Anderson Cancer Center
Start date September 2007
End date September 2016
Trial size 200 participants
Trial identifier NCT00532064, 2006-0921

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
Arm
Patients with advanced cancer receiving sunitinib malate or sorafenib chemotherapy.
questionnaire Survey
Symptom questionnaire taking about 10-15 minutes.

Primary Outcomes

Measure
Sensitivity of biomarkers for detecting cardiotoxicity
time frame: Monthly

Eligibility Criteria

Male or female participants from 18 years up to 85 years old.

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

Additional Information

Official title Early Detection of Cardiotoxicity During Sunitinib or Sorafenib Chemotherapy Using Cardiac Biomarkers
Principal investigator Elie Mouhayar, MD
Description The Blood Tests: Some chemotherapies are known to cause damage to heart muscle cells, resulting in heart failure. Often, the damage is not detected until heart failure has already occurred. Some studies have shown that the blood tests, troponin I and/or T, and BNP may be useful in detecting heart damage earlier than other tests currently performed (such as echocardiogram and electrocardiogram). Several studies have shown that measuring BNP levels is useful in the diagnosis of heart failure. BNP is produced by chambers in the heart in response to pressure and an overloaded amount of blood, and it is connected to both abnormalities in patients treated with doxorubicin. Short-term increases in BNP are seen after a patient is given a single dose of anthracycline, but the patients with BNP levels that stay elevated appear to have the greatest risk for developing heart-related side effects. BNP has also been shown to be elevated before the development of a type of heart problem in patients undergoing high-dose chemotherapy and stem cell transplantation. Other biomarkers for early doxorubicin side effects, such as the levels of troponins I and T in the blood, have recently been shown to be raised before changes in LVEF (Left Ventricular Ejection Fraction: the percentage of blood emptied from the left ventricle of the heart during contraction) and before the appearance of heart symptoms. There is no current standard for these blood tests. The use of biomarkers (blood tests) to predict heart-related side effects has not been fully tested and proven effective at this time. Study Visits: If you are found to be eligible to take part in this study, you will have 8 study visits, including the baseline (screening) visit and the end-of-study visit. Visit 1 will be 2 weeks after you begin chemotherapy. You will then have study visits about every 4-6 weeks (Visits 2-6). At VISIT 1, the following tests and procedures will be performed: - You will complete a questionnaire about any symptoms you may be experiencing. - You will have a physical exam, including measurement of vital signs. - Blood will be drawn for routine blood tests as a part of your standard-of-care. During this standard-of-care blood draw, additional blood (about 1 teaspoon) will be drawn to test troponin I and/or T and BNP levels. At VISIT 2, the following tests and procedures will be performed: - You will repeat the questionnaire about any symptoms you may be experiencing. - You will have a physical exam, including measurement of vital signs. - Blood will be drawn for routine blood tests as a part of your standard-of-care. During this standard-of-care blood draw, additional blood (about 1 teaspoon) will be drawn to test troponin I and/or T and BNP levels. - If the study doctor thinks it is necessary, you will have an ECG. - If the study doctor thinks it is necessary, you will have an echocardiogram. At VISITS 3, 5, and 6, the following tests and procedures will be performed: - If your study doctor thinks it is necessary, you will repeat the symptom questionnaire. - You will have a physical exam, including measurement of vital signs. - Blood will be drawn for routine blood tests as a part of your standard-of-care. During this standard-of-care blood draw, additional blood (about 1 teaspoon) will be drawn to test troponin I and/or T and BNP levels. At VISIT 4, the following tests and procedures will be performed: - You will repeat the symptom questionnaire. - You will have a physical exam, including measurement of vital signs. - Blood will be drawn for routine blood tests as a part of your standard-of-care. During this standard-of-care blood draw, additional blood (about 1 teaspoon) will be drawn to test troponin I and/or T and BNP levels. - You will have an ECG. - You will have an echocardiogram. At any time during the study, if your doctor thinks it is necessary, you will have an ECG and/or echocardiogram. Length of Study: This study will last about 6 months. End-of-Study Visit: About 6 months after you begin chemotherapy, you will have an end-of-study visit. At this visit the following tests and procedures will be performed: - You will fill repeat the symptom questionnaire. - You will have a physical exam, including measurement of vital signs. - Blood will be drawn for routine blood tests as a part of your standard-of-care. During this standard-of-care blood draw, additional blood (about 1 teaspoon) will be drawn to test troponin I and/or T and BNP levels. - You will have an ECG. - You will have an echocardiogram. This is an investigational study. Up to 200 patients will take part in this study. All will be enrolled at M. D. Anderson.
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.