Effectiveness of Using Biomarkers to Detect and Identify Cardiotoxicity and Describe Treatment (PREDICT)

Study Visits:

If you are found to be eligible to take part in this study, you will have study tests and
procedures performed on the same days as your visits for chemotherapy treatment. These study
visits will occur about every 3-4 weeks apart. The exact number and timing of the visits will
depend on when your scheduled chemotherapy visits occur. You and your doctor will discuss the
best chemotherapy treatment and schedule for you.

At each chemotherapy visit, before you receive your chemotherapy the following tests and
procedures will be performed:

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

At the beginning of every third cycle of chemotherapy you will be asked to complete a
questionnaire about any symptoms you may be experiencing.

Follow-Up Visit:

At about 6 months after starting your chemotherapy the following tests and procedures will be
performed:

- You will complete the symptom questionnaire.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

- You will have an ECG.

- You will have an ECHO or MUGA scan.

End-of-Study Visit:

At about 12 months after starting your chemotherapy you will have an end-of-study visit. At
this visit, the following tests and procedures will be performed:

- You will complete the symptom questionnaire.

- You will have a physical exam, including measurement of vital signs.

- Blood (about 2 teaspoons) will be drawn for routine tests.

- Additional blood (about 1 teaspoon) will be drawn for biomarker testing.

- You will have an ECG.

- You will have an ECHO or MUGA scan.

At any time during the study, if your doctor thinks it is necessary, you will have an ECG
and/or ECHO or MUGA scan.

If you stop receiving chemotherapy during your participation in this study, you will still be
asked to complete the above tests and procedures listed at the 12-month (end-of-study visit)
visit. Other tests and procedures scheduled during the study may not be performed because you
are no longer receiving chemotherapy treatment. Your study doctor and the research staff will
go over this information with you if this happens.

Research Test Results:

The primary biomarkers being tested in this study are the BNP and TnI. Both the BNP and TnI
look at the function of your heart. The BNP and TnI will both be tested at MD Anderson.

The results of the biomarker tests will be kept separately from your other tests results, and
will not affect your treatment in any way. The only reason your biomarker test results would
be shared with your cancer doctor would be if the study doctor thinks the results show a
heart problem. In that case, the study doctor will contact you right away to advise you about
what to do next (for example, coming in to the clinic). You will be referred to a
cardiologist (heart doctor) if the study doctor decides it is necessary.

In addition to the biomarkers being tested in this study, if you had ECHOs during the study,
the images of the ECHOs may be copied to a DVD and sent to the University of Pennsylvania for
review related to research on heart damage caused by anthracycline-based chemotherapy. Before
sending your ECHOs to the University of Pennsylvania MD Anderson will remove all of your
personal identifiers (name, date of birth, age, and medical record number) included on the
ECHO imaging DVD.

Length of Study Participation:

Your study participation will last about 12 months from date of your first chemotherapy
treatment. You will have a follow up visit at about 6 months from the date of your first
chemotherapy and an end of study visit at about 12 months from the date of your first
chemotherapy treatment. This will end your participation in the study.

This is an investigational study. At this time, the biomarker testing in this study is only
being used in research. Its use in detecting heart damage is considered investigational.

Up to 830 patients will take part in this multicenter study. Up to 200 will be enrolled at
the Harris Health System and MD Anderson.

Inclusion Criteria:

1. Patient age 18 years or older

2. Starting a new course of chemotherapy that includes an anthracycline (does not have to
be first-line therapy and previous anthracycline use is allowed)

3. Has a life expectancy greater than 12 months

Exclusion Criteria:

1. Unstable angina within the last 3 months of registration

2. Myocardial infarction within the last 3 months of registration

3. LVEF less than 50%

4. Patients receiving concurrent dexrazoxane

5. Decompensated Heart Failure in the last 3 months prior to registration

6. Prior symptomatic arrhythmia (within 3 months of study registration)

7. Severe pulmonary disease (FEV pulmonary artery pressure >/=60mm Hg), and/or dependent use of oxygen

8. BNP >/= 200 pg/ml or BNP >/= 200 pg/ml and troponin I >/= 0.4 ng/ml via use of the
Biosite Triage Profiler Note: BNP or BNP and TnI resulted in a local lab within 30
days of starting anthracycline based chemotherapy may be used in determining
eligibility. Results, either by the Biosite Triage Profiler or the local lab, > /= the
parameters described in exclusion 3.2.8 deem the patient ineligible for participation
in this study