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

Hypertension Clinical Trial

— SUPER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01014065
• Other study ID #: 00028 / 24942
• Status: Completed
• Phase: N/A
• First received: November 12, 2009
• Last updated: February 24, 2016
• Start date: July 2011
• Est. completion date: January 2013

Study information

• Verified date: March 2012
• Source: AHS Cancer Control Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: January 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Renal Cell
• Cardiotoxicity
• Heart Failure
• Hypertension
• Renal Cell Carcinoma

Locations

Country	Name	City	State
Canada	University of Alberta/ Cross Cancer Institute	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
AHS Cancer Control Alberta	Cross Cancer Institute

Country where clinical trial is conducted

Canada,