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

Tracking Information

First Received Date ^ICMJE

December 12, 2005

Last Updated Date

May 19, 2008

Start Date ^ICMJE

February 2005

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Blood specimens to measure TRAP level [ Time Frame: baseline, every 2 weeks for 6 weeks after the first Zometa infusion, then monthly until progression of bone metastatic disease ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

TRAP level measured at baseline, week 2/4/6, month 2/3/4/5/6

Change History

Complete list of historical versions of study NCT00265200 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Brief Pain Questionnaire to evaluate subject's pain [ Time Frame: at baseline, and months 2, 4, 6 ] [ Designated as safety issue: No ]
Bone imaging tests (bone scan, PET scan, MRI, and/or x-ray) will be done to measure progression of bone metastasis [ Time Frame: at baseline and 4 months after first Zometa infusion ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Brief Pain Inventory at baseline & month 3
Bone imaging at baseline, month 4, & as clinically indicated

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Condition ^ICMJE

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

Intervention ^ICMJE

Drug: zoledronic acid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

June 2009

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Jamie M Day, BSN	(502) 562-3429	jmluka01@louisville.edu
Contact: Kate K Rodger, MSHCM, BSN	(502) 562-3429	kkrodg01@louisville.edu

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00265200

Responsible Party

Goetz H. Kloecker, MD, James Graham Brown Cancer Center

Study ID Numbers ^ICMJE

565.04, BCC-LUN-04-002

Study Sponsor ^ICMJE

James Graham Brown Cancer Center

Collaborators ^ICMJE

University of Louisville
Novartis

Investigators ^ICMJE

Principal Investigator:

Goetz H Kloecker, MD, MSPH

James Graham Brown Cancer Center/ University of Louisville

Information Provided By

James Graham Brown Cancer Center

Verification Date

May 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP