A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients (SUnitinib Prospective CardiovasculaR Effect)

A Prospective Study of Acute Cardiovascular Effects of First-line Sunitinib in Metastatic Renal Cell Carcinoma Patients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01014065

Acronym

SUPER

Enrollment

Registered

2009-11-16

Start date

2011-07-31

Completion date

2013-01-31

Last updated

2016-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Heart Failure, Hypertension, Renal Cell Carcinoma

Keywords

sunitinib, cardiac MRI, maximal exercise testing, biomarkers, pharmacokinetics

Brief summary

While sunitinib can be very helpful to treat kidney cancer, these medications can also cause side effects, including heart damage. Studies performed in the past did not look at heart function in detail, so the investigators do not know what happens to the heart when people start sunitinib treatment. The aim of the study is to prospectively study acute effects of sunitinib on heart function, overall fitness and blood markers of heart disease.

Detailed description

Participants will undergo cardiac MRI, maximal exercise testing(VO2 peak), blood and urine samples before and after 2 treatments of sunitinib. An extra blood sample will be collected the 2nd week of the first treatment to check blood levels of sunitinib. We will also examine routine CT scans to study body composition.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Histologic diagnosis of metastatic renal cell carcinoma * Eligible to receive first-line sunitinib * Willingness to attend Cross Cancer Institute and University of Alberta for study-related assessments * Karnofsky Performance Status (KPS)82 ≥ 70 * Age ≥ 18 years of age * Adequate creatinine clearance to receive gadolinium * All patients with bone metastases are eligible; those with lesions identified at weight-bearing bones will undergo plain films to evaluate fracture risk prior to CPET; * Fluent in English language * No contraindication to MRI or other concern eg., metallic implants, claustrophobia

Exclusion criteria

* Prior systemic therapy for mRCC * Documented history of major cardiac event in last year i.e. MI, unstable angina, CABG, symptomatic CHF, CVA or TIA, or pulmonary embolism * Pregnancy * Other severe condition or abnormality that, in the judgement of the investigator or treating oncologist, would make participation in this study inappropriate * Unstable brain metastases

Countries

Canada

Outcome results