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


N/A
18 Years
N/A
Open (Enrolling)
Both
Renal Cell Carcinoma, Cardiotoxicity, Heart Failure, Hypertension

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Mark Haykowsky, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Alberta

Authority:

Canada: Health Canada

Study ID:

00028 / 24942

NCT ID:

NCT01014065

Start Date:

July 2011

Completion Date:

January 2013

Related Keywords:

  • Renal Cell Carcinoma
  • Cardiotoxicity
  • Heart Failure
  • Hypertension
  • sunitinib
  • cardiac MRI
  • maximal exercise testing
  • biomarkers
  • pharmacokinetics
  • Carcinoma
  • Carcinoma, Renal Cell
  • Heart Failure
  • Hypertension

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