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

AHS Cancer Control Alberta

Status: Completed

Conditions: Cardiotoxicity; Hypertension; Heart Failure; Renal Cell Carcinoma

Study type: Observational

Funder types: Other

Identifiers

NCT01014065

00028 / 24942

Details and patient eligibility

About

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.

Full 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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

42 participants in 1 patient group

1

Description:

Patients with renal cell carcinoma scheduled to receive sunitinib