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

Primary Purpose

Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung, Metastases

Status

Terminated

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

zoledronic acid

About this trial

This is an interventional diagnostic trial for Carcinoma, Non-Small Cell Lung focused on measuring Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase

Eligibility Criteria

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

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

Sites / Locations

James Graham Brown Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

zoledronic acid

Arm Description

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Outcomes

Primary Outcome Measures

Average Percent Change From Baseline in TRAP Levels at 2 Weeks

Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline

Secondary Outcome Measures

Full Information

NCT ID

NCT00265200

First Posted

December 12, 2005

Last Updated

March 1, 2018

Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center, Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT00265200

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Terminated

Why Stopped

funding discontinued by sponsor

Study Start Date

February 2005 (undefined)

Primary Completion Date

August 2009 (Actual)

Study Completion Date

December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Louisville

Collaborators

James Graham Brown Cancer Center, Novartis Pharmaceuticals

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

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.

6. Conditions and Keywords

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

Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung, Metastases

Keywords

Zometa, bone metastasis, lung cancer, non-small cell lung cancer, small cell lung cancer, bone metabolic markers, tartrate resistant acid phosphatase

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

zoledronic acid

Arm Type

Experimental

Arm Description

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Intervention Type

Drug

Intervention Name(s)

zoledronic acid

Other Intervention Name(s)

Zometa

Intervention Description

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Primary Outcome Measure Information:

Title

Average Percent Change From Baseline in TRAP Levels at 2 Weeks

Description

Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline

Time Frame

TRAP levels at Baseline and 2 weeks after first Zometa infusion

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Goetz H Kloecker, MD, MSPH

Organizational Affiliation

James Graham Brown Cancer Center/ University of Louisville

Official's Role

Principal Investigator

Facility Information:

Facility Name

James Graham Brown Cancer Center

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

12. IPD Sharing Statement

Links:

URL

http://www.browncancercenter.org

Description

James Graham Brown Cancer Center

Learn more about this trial

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

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