EARLY DETECTION OF BROKEN HEARTS IN CANCER PATIENTS: BEVACIZUMAB, SUNITINIB AND HEART FAILURE

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80 at Mayo Clinic [40 receiving BVZ and 40 receiving Sunitinib] and 20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv every 2-3 weeks for colorectal cancer or Sunitinib 50 mg po daily for advanced Metastatic renal cell carcinoma will be screened for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. At each visit, in addition to standard of care provided by the Oncologist, blood will be drawn to measure high sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and 3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.

Who is eligible to participate?

Inclusion Criteria: 1. Patients with advanced cancer (colorectal, renal cell, GIST) 2. Treatment plan includes BVZ or Sunitinib 3. Ages 18 - 90 years old - Exclusion Criteria: Left Ventricular EF < 50% -

Last updated:

3/11/2014

NCT ID:

NCT02086695

IRB Number:

12-005362