RAZOR

Full title: RAD001 and ZOledronic acid in Renal cell carcinoma patients with bone metastases – a randomised phase II trial
Cancer type: Renal cell
Status: Closed (30 participants recruited)
Brief description:

 

The main purpose of this study is to assess if RAD001 plus zoledronic acid, is a more effective treatment for patients with renal cell carcinoma and bone metastases compared to RAD001 alone.

Participants will be allocated to one of these two treatments with equal chances of each treatment being the one received.

Patients’ must have previously untreated advanced renal cell carcinoma, with at least one measurable bone metastases. Patients must be aged 18 years or older.

Zoledronic acid will be given as an intravenous venous (IV) infusion over 15 minutes once every 28 days. RAD001 will be taken by mouth, in tablet form, 10 mg every day.

Participants will undergo tests (medical history, physical examinations, blood & urine tests, electrocardiograms (ECG), a dental examination and Computerised Tomography (CT) scan to confirm they can enter the study.
Patients will be assessed every 28 days and have similar tests to monitor progress and identify and treat any side effects.

After the 12 week bone specific assessment period, subjects continue on therapy, on the treatment arm to which they are allocated, until one of the following criteria applies:

a) Disease progression
b) Intercurrent illness that prevents further administration of treatment
c) Unacceptable adverse events(s)
d ) Patient decides to withdraw from the study
e) General or specific changes in the patient’s condition render the patient unacceptable for further treatment in the judgment of the investigator.

Sites: ·        Auckland

·        Waikato

·        Tauranga

·        Palmerston North

·        Wellington

·        Christchurch

Lead Investigator: Dr Reuben Broom
Contact: Sarah Benge (s.benge@auckland.ac.nz)
Sponsor: UniServices
Funder: Novartis
Trial Registry reference: ACTRN12609000980235 (click for more details)
Ethics number: MEC/09/12/134
Publications: Broom RJ, Hinder V, Sharples K, Proctor J, Duffey S, Pollard S, Fong PCC, Forgeson G, Harris DL, Jameson MB, O’Donnell A, North RT, Deva S, Hanning FJ, Grey A, Findlay MPN. Everolimus and zoledronic acid in patients with renal cell carcinoma with bone metastases: A randomized first-line phase II trial. Clinical Genitourinary Cancer. 2015 Feb; 13(1): 50-58.