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

NCT ID: NCT01014065

Last Updated: 2016-02-25

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 42 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-07-31
• Study Completion Date: 2013-01-31

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.

Conditions

Renal Cell Carcinoma; Cardiotoxicity; Heart Failure; Hypertension

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Patients with renal cell carcinoma scheduled to receive sunitinib

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cross Cancer Institute

OTHER

Sponsor Role: collaborator

AHS Cancer Control Alberta

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Haykowsky, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Countries

Canada

Other Identifiers

00028 / 24942

Identifier Type: -

Identifier Source: org_study_id