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

Sponsor

AHS Cancer Control Alberta (Other)

Overall Status

Completed

CT.gov ID

NCT01014065

Collaborator

Cross Cancer Institute (Other)

Enrollment

Location

18.1

Duration (Months)

2.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Cell Carcinoma Cardiotoxicity Heart Failure Hypertension

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.

Study Design

Study Type:

Observational

Actual Enrollment :

42 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jul 1, 2011

Actual Primary Completion Date :

Nov 1, 2012

Actual Study Completion Date :

Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
1 Patients with renal cell carcinoma scheduled to receive sunitinib

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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