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

NCT01014065 | Completed

• 1 other identifier: 00028 / 24942
• Study Type: observational
• Target: 42
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cell Carcinoma; Cardiotoxicity; Heart Failure; Hypertension

Keywords

sunitinib; cardiac MRI; maximal exercise testing; biomarkers; pharmacokinetics

Study Arms (1)

1

Patients with renal cell carcinoma scheduled to receive sunitinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with renal cell carcinoma scheduled to receive sunitinub.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AHS Cancer Control Alberta: lead
• Cross Cancer Institute: collaborator

Study Sites (1)

University of Alberta/ Cross Cancer Institute

Edmonton, Alberta, Canada

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood and urine banked

MeSH Terms

Conditions

Carcinoma, Renal Cell; Cardiotoxicity; Heart Failure; Hypertension

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries; Vascular Diseases

Study Officials

• Mark Haykowsky, PhD

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2009
• First Posted: November 16, 2009
• Study Start: July 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: January 1, 2013
• Last Updated: February 25, 2016

Record last verified: 2012-03

Locations

CA (1)