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The Cardiovascular Effects of Sunitinib Therapy: Off Target Changes in Cardiac Metabolism and Ventricular Vascular Mechanics (CREST)


N/A
18 Years
N/A
Open (Enrolling)
Both
Patients With Renal Cell Carcinoma Who Are Newly Initiating Therapy, With the Oral Tyrosine-kinase Inhibitor Sunitinib.

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Trial Information

The Cardiovascular Effects of Sunitinib Therapy: Off Target Changes in Cardiac Metabolism and Ventricular Vascular Mechanics (CREST)


Tyrosine kinase inhibitors such as sunitinib have dramatically improved the overall
management of certaincancers including renal cell carcinoma. However, recent data suggest
that these therapieshave significant off-target effects with cardiac toxicity, including
significant hypertension and ventricular cardiac dysfunction being a major concern.
However, the biologic mechanisms underlying cardiotoxicty in humans remain poorly defined.
Moreover, there is a critical need to develop methods to improve the risk stratification and
early identification of patients who will suffer from hypertension and cardiac dysfunction
with exposure to therapy. The over all objectives ofthis study are to further characterize
the cardiovascular changes that occur with sunitinib exposure in order to improve our
understanding of sunitib toxicity and determine early, mechanistically and clinically
relevant predictors to identify patients at increased risk of hyptertension and cardiac
dysfunction. The specific aims of this study are: 1) To define the changes in arterial
hemodynamics that may occur with exposure to sunitinib, 2) To define the changes in
sensitive echocardiographic measures of cardiac function that may occur with exposure to
sunitinib, 3) To determine blood markers that are associated with changes in vasculature or
cardiac function with exposure to sunitinib. and 4) To determine if there are early imaging
or biomarker predictors of subitinib cardiotoxicity.


Inclusion Criteria:



- Patients with renal cell carcinoma newly undergoing therapy with sunitinib.

- Age greater than or equal to 18 years

- ECOG performance status 0,1,2

Exclusion Criteria:

- Any contraindication to sunitinib therapy of note, patients with prior cardiovascular
history are not excluded from this study, as long as there are no contraindications
to sunitinib therapy.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Change from Baseline in Systolic Blood Pressure at 6 months.

Safety Issue:

Yes

Authority:

United States: Institutional Review Board

Study ID:

UPCC 34810

NCT ID:

NCT01370109

Start Date:

April 2011

Completion Date:

April 2014

Related Keywords:

  • Patients With Renal Cell Carcinoma Who Are Newly Initiating Therapy
  • With the Oral Tyrosine-kinase Inhibitor Sunitinib.
  • Carcinoma
  • Carcinoma, Renal Cell

Name

Location

Abramson Cancer Center, University of PennsylvaniaPhiladelphia, Pennsylvania  19104