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A Study Comparing Denosumab to Standard Treatment in Patients with Bone Metastases.

Trial ID: NCT03520231
Kidney Cancer Type: Collecting Duct Cancers, Medullary Cancers, and Cancers with Sarcomatoid Features.


Background:

Up to 30% of patients with advanced kidney cancer may develop bone tumours which have spread from their primary kidney cancer. These bone tumours can be painful and significantly reduce a patient’s quality of life.

Denosumab (XGEVA®) is a drug that helps prevent bone damage in patients with metastatic cancer and is already Health Canada-approved for use in some blood and bone cancers.

Platinum Chemotherapy refers to a broad group of chemotherapy drugs which are commonly used in many cancers, but are less common in kidney cancer. These drugs have been shown to be effective in kidney cancer, but primarily among patients with rarer subtypes, including Collecting Duct Cancers, Medullary Cancers, and Cancers with Sarcomatoid Features.


The Trial:

This study will investigate the safety and effectiveness of adding denosumab to a standard regimen of platinum chemotherapy. The main objective is to determine the effectiveness of denosumab at helping patients cope with pain and mobility challenges caused by their bone tumours. The chemotherapy in this trial will contain either gemcitabine (Gemzar®) and cisplatin (Platinol®), or gemcitabine and carboplatin (Paraplatin®).


Basic Eligibility:

  • Eligible to start platinum chemotherapy
    • Collecting Duct Cancers, Medullary Cancers, and Cancers with Sarcomatoid Features.
  • Tumours have spread to the bone

Additional eligibility criteria will apply. Please speak to your doctor.

 

Find out more about this study
Hospital / Cancer CentrePrincipal InvestigatorLocationTrial Status
Hospital / Cancer CentrePrincess Margaret Cancer Centre Principal InvestigatorDr. Srikala Sridhar LocationToronto, ON Trial StatusRecruiting
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