Back to results

Zoledronate With Atorvastatin in Renal Cell Carcinoma

Primary Purpose

Kidney Cancer, Renal Cell Carcinoma

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Zoledronate

Atorvastatin

About this trial

This is an interventional treatment trial for Kidney Cancer focused on measuring Kidney Cancer, Renal Cell Carcinoma, Bone-Targeted Therapy, Zoledronate, Zometa, Atorvastatin, Lipitor, RCC

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Histologically confirmed renal cell carcinoma
Must have evidence of predominant bone metastases on X-rays, bone scan, MRI or CT scan. No requirement for bidimensionally measurable lesions.
Impending complications (such as pathological fractures and spinal cord compressions) from skeletal metastases must be controlled by surgery or radiation therapy.
Patients with prior or on concurrent immunotherapy or chemotherapy are eligible, excluding those on drugs that will interact with statins (Cytochrome P450 2C9 Pathway).
Patients with prior or concurrent treatment with bisphosphonates or statins are eligible.
Patients with hypercalcemia are eligible.
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.
Patients must sign an informed consent indicating that they are aware of the investigational nature of this study.

Exclusion Criteria:

Patients of childbearing potential not practicing adequate contraception.
Patients with poor dentition or recent major dental procedures.
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.
Overt psychosis or mental disability or otherwise incompetent to give informed consent.
Known hypersensitivity to Zometa (zoledronic acid), other bisphosphonates, or to fluvastatin.
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.
Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction, implants)
Active liver disease or unexplained persistent elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times upper limits of normal (ULN)
Serum creatine kinase (CK) > 3 times ULN
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.
History of alcohol abuse as such condition independently predisposes patients to myopathy.

Sites / Locations

UT MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Zoledronate + Atorvastatin

Arm Description

Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily

Outcomes

Primary Outcome Measures

Median Time to First Skeletal-related Event

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00490698

First Posted

June 21, 2007

Last Updated

February 13, 2013

Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00490698

Brief Title

Zoledronate With Atorvastatin in Renal Cell Carcinoma

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2013

Overall Recruitment Status

Completed

Study Start Date

October 2006 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

M.D. Anderson Cancer Center

Collaborators

Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Objectives: Primary: Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy Secondary: Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases Measure bone-formation and resorption markers at baseline and during bone-targeted therapy. Assess effect of the bone-targeted regimen on serum cholesterol levels

Detailed Description

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. Anderson.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Kidney Cancer, Renal Cell Carcinoma

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

11 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Zoledronate + Atorvastatin

Arm Type

Experimental

Arm Description

Zoledronate 4 mg intravenous (IV) once every 4 Weeks + Atorvastatin 20 mg orally (PO) daily

Intervention Type

Drug

Intervention Name(s)

Zoledronate

Other Intervention Name(s)

Zometa

Intervention Description

4 mg IV Once Every 4 Weeks

Intervention Type

Drug

Intervention Name(s)

Atorvastatin

Other Intervention Name(s)

Lipitor

Intervention Description

20 mg PO Daily

Primary Outcome Measure Information:

Title

Median Time to First Skeletal-related Event

Description

Time Frame

Up to 1 year

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Histologically confirmed renal cell carcinoma Must have evidence of predominant bone metastases on X-rays, bone scan, MRI or CT scan. No requirement for bidimensionally measurable lesions. Impending complications (such as pathological fractures and spinal cord compressions) from skeletal metastases must be controlled by surgery or radiation therapy. Patients with prior or on concurrent immunotherapy or chemotherapy are eligible, excluding those on drugs that will interact with statins (Cytochrome P450 2C9 Pathway). Patients with prior or concurrent treatment with bisphosphonates or statins are eligible. Patients with hypercalcemia are eligible. 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. Patients must sign an informed consent indicating that they are aware of the investigational nature of this study. Exclusion Criteria: Patients of childbearing potential not practicing adequate contraception. Patients with poor dentition or recent major dental procedures. 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. Overt psychosis or mental disability or otherwise incompetent to give informed consent. Known hypersensitivity to Zometa (zoledronic acid), other bisphosphonates, or to fluvastatin. 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. Recent (within 6 weeks) or planned dental or jaw surgery (e.g., extraction, implants) Active liver disease or unexplained persistent elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2 times upper limits of normal (ULN) Serum creatine kinase (CK) > 3 times ULN 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. History of alcohol abuse as such condition independently predisposes patients to myopathy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Shi-Ming Tu, MD

Organizational Affiliation

M.D. Anderson Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

UT MD Anderson Cancer Center

City

Houston

State/Province

Texas

ZIP/Postal Code

77030

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

21958521

Citation

Manoukian 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.

Results Reference

result

Links:

URL

http://mdanderson.org

Description

The University of Texas (UT) MD Anderson Cancer Center official website

Learn more about this trial

Zoledronate With Atorvastatin in Renal Cell Carcinoma

We'll reach out to this number within 24 hrs