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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) (SUPER)

This study is currently recruiting participants.
Verified March 2012 by Alberta Health Services
Sponsor:
Information provided by (Responsible Party):
Alberta Health Services
ClinicalTrials.gov Identifier:
NCT01014065
First received: November 12, 2009
Last updated: March 30, 2012
Last verified: March 2012
History of Changes
  Purpose

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
Renal Cell Carcinoma
Cardiotoxicity
Heart Failure
Hypertension

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Alberta Health Services:

Biospecimen Retention:   Samples With DNA

Blood and urine banked


Estimated Enrollment: 42
Study Start Date: July 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients with renal cell carcinoma scheduled to receive sunitinib

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with renal cell carcinoma scheduled to receive sunitinub.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01014065

Contacts
Contact: Edith Pituskin, RN MN (PhD Student) 780-432-8792 pituskin@ualberta.ca

Locations
Canada, Alberta
University of Alberta/ Cross Cancer Institute Recruiting
Edmonton, Alberta, Canada
Principal Investigator: Mark Haykowsky, PhD            
Sponsors and Collaborators
Alberta Health Services
Investigators
Principal Investigator: Mark Haykowsky, PhD University of Alberta
  More Information

No publications provided

Responsible Party: Alberta Health Services
ClinicalTrials.gov Identifier: NCT01014065     History of Changes
Other Study ID Numbers: 00028 / 24942
Study First Received: November 12, 2009
Last Updated: March 30, 2012
Health Authority: Canada: Health Canada

Keywords provided by Alberta Health Services:
sunitinib
cardiac MRI
maximal exercise testing
biomarkers
pharmacokinetics

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Renal Cell
Heart Failure
Hypertension
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
 Urologic Diseases
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on May 23, 2013