Clinical trial · Interventional
Zoledronate With Atorvastatin in Renal Cell Carcinoma
Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study
NCT00490698CI-TRIAL-00009747completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Objectives: Primary: Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy Secondary: 1. Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases 2. Measure bone-formation and resorption markers at baseline and during bone-targeted therapy. 3. Assess effect of the bone-targeted regimen on serum cholesterol levels
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Kidney Cancer | Malignant Kidney Neoplasm | CURATED_EXACT | 0.92 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Zoledronate | Drug | Zoledronic Acid | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zoledronate + Atorvastatin
- description
- Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily
- interventionNames
- Drug: Zoledronate
- Drug: Atorvastatin
Primary outcomes (1)
- measure
- Median Time to First Skeletal-related Event
- timeFrame
- Up to 1 year
- description
- Time to skeletal events, defined as a metastatic site requiring radiotherapy or any surgical intervention (eg, embolization, radiofrequency ablation, intrathecal catheter placement) or complications from skeletal metastatic lesions (eg, pathologic fracture, spinal cord compression). Time to skeletal events monitored every 8 weeks for at least 1 year.
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Histologically confirmed renal cell carcinoma 2. Must have evidence of predominant bone metastases on X-rays, bone scan, MRI or CT scan. No requirement for bidimensionally measurable lesions. 3. Impending complications (such as pathological fractures and spinal cord compressions) from skeletal metastases must be controlled by surgery or radiation therapy. 4. Patients with prior or on concurrent immunotherapy or chemotherapy are eligible, excluding those on drugs that will interact with statins (Cytochrome P450 2C9 Pathway). 5. Patients with prior or concurrent treatment with bisphosphonates or statins are eligible. 6. Patients with hypercalcemia are eligible. 7. Adequate physiologic reserves as evidenced by:Zubrod performance status of \</= 2; Transaminase and conjugated bilirubin less than twice the upper limit of normal; Creatinine Clearance \>/= 30 ml/min. 8. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Exclusion Criteria: 1. Patients of childbearing potential not practicing adequate contraception. 2. Patients with poor dentition or recent major dental procedures. 3. History of other malignancies other than non-melanoma skin cancer or carcinoma-in-situ of the cervix unless in complete remission and off therapy for that disease for at least 5 years. 4. Overt psychosis or mental disability or otherwise incompetent to give informed consent. 5. Known hypersensitivity to Zometa (zoledronic acid), other bisphosphonates, or to fluvastatin. 6. Current active dental problems including infection of the teeth or jawbone (maxilla or mandibular); dental or fixture trauma, or a current or prior diagnosis of osteonecrosis of the jaw (ONJ), of exposed bone in the mouth, or of slow healing after dental procedures. 7. Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction, implants) 8. Active liver disease or unexplained persistent elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 times upper limits of normal (ULN) 9. Serum creatine kinase (CK) \> 3 times ULN 10. Patients taking concurrent agents that may increase risk of myopathy such as fibric acid derivatives, nicotinic acid, cyclosporine, azole antifungals (itraconazole, ketoconazole, and fluconazole), macrolide antibiotics (erythromycin, clarithromycin, HIV protease inhibitors, nefazodone, delavirdine, cyclosporine, and grapefruit juice. 11. History of alcohol abuse as such condition independently predisposes patients to myopathy.
References
Publications (1)
- RESULTManoukian GE, Tannir NM, Jonasch E, Qiao W, Haygood TM, Tu SM. Pilot trial of bone-targeted therapy combining zoledronate with fluvastatin or atorvastatin for patients with metastatic renal cell carcinoma. Clin Genitourin Cancer. 2011 Dec;9(2):81-8. doi: 10.1016/j.clgc.2011.07.001. Epub 2011 Oct 1. PMID 21958521