NCT00490698

Brief Summary

Objectives: Primary: Evaluate clinical outcome based on the time to skeletal events after bone-targeted therapy Secondary:

  1. 1.Evaluate clinical outcome based on the presence of calcification at the site of osteolytic metastases
  2. 2.Measure bone-formation and resorption markers at baseline and during bone-targeted therapy.
  3. 3.Assess effect of the bone-targeted regimen on serum cholesterol levels

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Oct 2006

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2007

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2012

Completed
1.2 years until next milestone

Results Posted

Study results publicly available

March 18, 2013

Completed
Last Updated

March 18, 2013

Status Verified

February 1, 2013

Enrollment Period

5.3 years

First QC Date

June 21, 2007

Results QC Date

February 13, 2013

Last Update Submit

February 13, 2013

Conditions

Kidney CancerRenal Cell Carcinoma

Keywords

Kidney CancerRenal Cell CarcinomaBone-Targeted TherapyZoledronateZometaAtorvastatinLipitorRCC

Outcome Measures

Primary Outcomes (1)

  • 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.

    Up to 1 year

Study Arms (1)

Zoledronate + Atorvastatin

EXPERIMENTAL

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

Drug: ZoledronateDrug: Atorvastatin

Interventions

ZoledronateDRUG

4 mg IV Once Every 4 Weeks

Also known as: Zometa
Zoledronate + Atorvastatin
AtorvastatinDRUG

20 mg PO Daily

Also known as: Lipitor
Zoledronate + Atorvastatin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UT MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • 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.

    PMID: 21958521RESULT

Related Links

MeSH Terms

Conditions

Kidney NeoplasmsCarcinoma, Renal Cell

Interventions

Zoledronic AcidAtorvastatin

Condition Hierarchy (Ancestors)

Urologic NeoplasmsUrogenital NeoplasmsNeoplasms by SiteNeoplasmsFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesKidney DiseasesUrologic DiseasesMale Urogenital DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrrolesHeptanoic AcidsFatty AcidsLipids

Results Point of Contact

Title
Shi-Ming Tu, MD / Professor
Organization
The University of Texas (UT) MD Anderson Cancer Center
CR_Study_Registration@mdanderson.org

Study Officials

  • Shi-Ming Tu, MD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 21, 2007

First Posted

June 25, 2007

Study Start

October 1, 2006

Primary Completion

January 1, 2012

Study Completion

January 1, 2012

Last Updated

March 18, 2013

Results First Posted

March 18, 2013

Record last verified: 2013-02

Locations

US(1)