Zoledronate With Atorvastatin in Renal Cell Carcinoma

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: M.D. Anderson Cancer Center
• Collaborator: Novartis Pharmaceuticals
• Treatments: Atorvastatin; Atorvastatin Calcium; Diphosphonates; Zoledronic Acid

Criteria

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 ofTransaminase 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.