Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer

March 1, 2018 updated by: Goetz Kloecker, University of Louisville

Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer

The purpose of this study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases due to lung cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to evaluate a new blood test as a way to follow the effect of Zometa in treating bone metastases. The blood test will look for a protein, called TRAP, which is released into the blood stream by the breakdown of bone. This study will compare the TRAP blood test with other blood tests for bone destruction.

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • James Graham Brown Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • invasive lung cancer (small cell or non-small cell lung cancer)
  • osteolytic bone metastasis determined by clinical exam, bone scan/XR
  • age > 18 years

Exclusion Criteria:

  • concurrent malignancy with a second primary
  • renal failure (serum creatinine > 3mg/dl)
  • pregnancy
  • active rheumatoid arthritis
  • intolerance to zoledronic acid

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Drug: zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Other Names:
  • Zometa

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average Percent Change From Baseline in TRAP Levels at 2 Weeks
Time Frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion
Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline
TRAP levels at Baseline and 2 weeks after first Zometa infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

Novartis Pharmaceuticals
James Graham Brown Cancer Center

Investigators

  • Principal Investigator: Goetz H Kloecker, MD, MSPH, James Graham Brown Cancer Center/ University of Louisville

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2005

Primary Completion (Actual)

August 1, 2009

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

December 12, 2005

First Submitted That Met QC Criteria

December 12, 2005

First Posted (Estimate)

December 14, 2005

Study Record Updates

Last Update Posted (Actual)

March 5, 2018

Last Update Submitted That Met QC Criteria

March 1, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 565.04
  • BCC-LUN-04-002 (Other Identifier: James Graham Brown Cancer Center Clinical Trials Office)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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