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Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study

Phase 2
Not Enrolling
Kidney Cancer, Renal Cell Carcinoma

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Trial Information

Bone-Targeted Therapy Combining Zoledronate With Atorvastatin in Renal Cell Carcinoma: A Phase II Study

Kidney cancer often spreads (metastases) to the bones. Zoledronate is designed to protect
the bones from pain and from breaking as a result of cancer. Atorvastatin is a drug that
lowers cholesterol levels in the blood. Combining these medications may make zoledronate
more effective.

If you are found to be eligible to take part in this study, you will be given zoledronate
intravenously (IV--through a needle in your vein) over fifteen minutes,1 time every 4 weeks.
You will take a pill, atorvastatin, by mouth once time a day every day that you are on the
study. Every 4 weeks is considered 1 study "cycle".

You will need to return to M. D. Anderson for check-ups every 8 -12 weeks. Urine will be
collected for routine tests. You will have x-rays, bone scans, and/or CT scans to check on
the status of the disease.

You will receive at least 2 cycles of treatment unless intolerable side effects occur or
your disease gets worse. You may receive more than 2 cycles if you are benefitting from the
study drugs.

You will be followed every 8 weeks for up to 1 year for skeletal events (symptoms related to
disease moving to or getting worse in your bones). You will be taken off study if you
experience a skeletal event or at the end of the 1-year monitoring period. Monitoring may
be done with a local doctor or at M. D. Anderson. No extra testing or procedures are needed
during this period.

This is an investigational study. The combination of the 2 drugs given in this study is
investigational for the treatment of bone metastases. Zoledronate is approved for the
treatment of bone metastases. Atorvastatin has been approved by the FDA for lowering
cholesterol. About 38 patients will take part in this study. All will be enrolled at M. D.

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

5. Patients with prior or concurrent treatment with bisphosphonates or statins are

6. Patients with hypercalcemia are eligible.

7. Adequate physiologic reserves as evidenced by:Zubrod performance status of 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

5. Known hypersensitivity to Zometa (zoledronic acid), other bisphosphonates, or to

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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Median Time to First Skeletal-related Event

Outcome 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.

Outcome Time Frame:

Up to 1 year

Safety Issue:


Principal Investigator

Shi-Ming Tu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

M.D. Anderson Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

October 2006

Completion Date:

January 2012

Related Keywords:

  • Kidney Cancer
  • Renal Cell Carcinoma
  • Kidney Cancer
  • Renal Cell Carcinoma
  • Bone-Targeted Therapy
  • Zoledronate
  • Zometa
  • Atorvastatin
  • Lipitor
  • RCC
  • Carcinoma
  • Carcinoma, Renal Cell
  • Kidney Neoplasms



UT MD Anderson Cancer Center Houston, Texas  77030