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

This study is currently recruiting participants.

Verified by James Graham Brown Cancer Center, May 2008

First Received: December 12, 2005 Last Updated: May 19, 2008 History of Changes

Sponsor:	James Graham Brown Cancer Center
Collaborators:	University of Louisville Novartis
Information provided by:	James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:	NCT00265200

Purpose

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.

Condition	Intervention	Phase
Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases	Drug: zoledronic acid	Phase II

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Lung Cancer

Drug Information available for: Zoledronic acid

U.S. FDA Resources

Further study details as provided by James Graham Brown Cancer Center:

Primary Outcome Measures:

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 ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	40
Study Start Date:	February 2005
Estimated Study Completion Date:	June 2009
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00265200

Contacts

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

Locations

United States, Kentucky
James Graham Brown Cancer Center	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Jamie M Day, BSN 502-562-3429 jmluka01@louisville.edu
Principal Investigator: Goetz H Kloecker, MD, MSPH
Sub-Investigator: Donald M Miller, MD, PhD
Sub-Investigator: Vivek Sharma, MD
Sub-Investigator: Damian Laber, MD
Sub-Investigator: Dharmvir Jain, MD

Sponsors and Collaborators

James Graham Brown Cancer Center

University of Louisville

Novartis

Investigators

Principal Investigator:

Goetz H Kloecker, MD, MSPH

James Graham Brown Cancer Center/ University of Louisville

More Information

Additional Information:

James Graham Brown Cancer Center This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	James Graham Brown Cancer Center ( Goetz H. Kloecker, MD )
Study ID Numbers:	565.04, BCC-LUN-04-002
Study First Received:	December 12, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00265200 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by James Graham Brown Cancer Center:

Zometa
bone metastasis
lung cancer
non-small cell lung cancer

small cell lung cancer
bone metabolic markers
tartrate resistant acid phosphatase

Additional relevant MeSH terms:

Thoracic Neoplasms
Carcinoma, Neuroendocrine
Neoplasms, Nerve Tissue
Physiological Effects of Drugs
Bone Density Conservation Agents
Neoplastic Processes
Neoplasms by Site
Pathologic Processes
Respiratory Tract Diseases
Lung Neoplasms
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Respiratory Tract Neoplasms

Neoplasms by Histologic Type
Zoledronic acid
Pharmacologic Actions
Carcinoma
Neuroendocrine Tumors
Carcinoma, Small Cell
Neuroectodermal Tumors
Neoplasms
Lung Diseases
Adenocarcinoma
Carcinoma, Non-Small-Cell Lung
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on November 22, 2009