The effect of RAD001 and Zoledronic acid in Renal cell cancer which has spread to the bones.
- Conditions
- Renal Cell CarcinomaCancer - BoneBone metastasesCancer - Kidney
- Registration Number
- ACTRN12609000980235
- Lead Sponsor
- niservices
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1. Patients must have histologically or cytologically confirmed renal cell carcinoma (RCC) 2. Patients must have evidence of at least one bone metastasis on imaging 3. Patients must not have received any prior therapy for advanced RCC. Prior radiotherapy is allowed, but must have been completed at least 4 weeks prior to randomisation. Prior systemic adjuvant therapy in a clinical trial is allowed. Prior bisphosphonates are allowed, but not within 4 weeks of study randomisation. Prior immunotherapy for advanced RCC is not allowed 4. Age >18 years 5. Life expectancy of greater than 3 months 6. Eastern Cooperative Oncology Group (ECOG) performance status <2 7. Patients must have normal organ and marrow function as defined as Haemoglobin >90 g/l, WBC >3.0 x109/L, Absolute Neutrophil Count > 1/5 x109/L, Platelets >100 x109/L, Bilirubin-within normal limits, ASL/ALT <2.5 ULN, Calcium 2.0-3.0 mmol/L, Creatinine Clearance >35 ml/min 8. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation 9. Fasting serum cholesterol less than or equal to 7.75 mmol/L and fasting triglycerides less than or equal to 2.5 x upper limit of normal (ULN). In case one or both of these thresholds are exceeded, the patient can only be included after initiation of statin therapy and when the above mentioned values have been achieved 10. Ability to understand and the willingness to sign a written informed consent document
1. Patients who have had radiotherapy or bisphosphonates within 4 weeks prior to entering the study 2. Patients may not be receiving any other investigational agents. 3. Patients with known brain metastases are excluded from this clinical trial unless they have undergone definitive treatment with either surgery or whole brain radiotherapy and been neurologically stable for > 6 weeks. Patients should either be off corticosteroids, or down to a low dose (less than or equal to 2mg dexamethasone or less than or equal to 10mg prednisone daily) and if still on corticosteroids, they must have normal glycaemic control. 4. History of allergic reactions attributed to compounds of similar chemical or biologic composition to RAD001 or zoledronic acid 5. Patients receiving any medications or substances that are potent inhibitors or inducers of CYP450 3A4 6. Uncontrolled intercurrent illness 7. Uncontrolled or brittle diabetes mellitus 8. Pregnant or breastfeeding women 9. Human Immunodeficiency Virus (HIV) -positive patients on combination antiretroviral therapy 10. Current active dental problems 11. Recent (within 6 weeks) or planned dental or jaw surgery 12. Prior organ transplantation on immunosuppressants 13. Patients with concurrent active second malignancy are ineligible 14. Patients who are HBsAg +ve AND who have not been commenced on appropriate HBV prophylaxis (e.g. lamivudine)
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to assess the ability of RAD001 alone compared to the combination of RAD001 and ZA to control bone metastases from renal cell carcinoma by measuring the urinary N-telopeptide (uNTX) levels over a 12 week period.[uNTX will be measured at baseline, and on day one of weeks 1, 4, 8 and 12.]
- Secondary Outcome Measures
Name Time Method