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

This study has been completed.
Sponsor:
Collaborator:
Cross Cancer Institute
Information provided by (Responsible Party):
AHS Cancer Control Alberta
ClinicalTrials.gov Identifier:
NCT01014065
First received: November 12, 2009
Last updated: February 24, 2016
Last verified: March 2012

November 12, 2009
February 24, 2016
July 2011
November 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01014065 on ClinicalTrials.gov Archive Site
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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
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:
Blood and urine banked
Probability Sample
Patients with renal cell carcinoma scheduled to receive sunitinub.
  • Renal Cell Carcinoma
  • Cardiotoxicity
  • Heart Failure
  • Hypertension
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1
Patients with renal cell carcinoma scheduled to receive sunitinib
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
42
January 2013
November 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01014065
00028 / 24942
No
Not Provided
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AHS Cancer Control Alberta
AHS Cancer Control Alberta
Cross Cancer Institute
Principal Investigator: Mark Haykowsky, PhD University of Alberta
AHS Cancer Control Alberta
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP