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

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

MedlinePlus related topics:

Cancer Lung Cancer

ChemIDplus related topics:

Zoledronic acid

U.S. FDA Resources

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

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

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

Responsible Party:	James Graham Brown Cancer Center ( Goetz H. Kloecker, MD )
Study ID Numbers:	565.04, BCC-LUN-04-002
First Received:	December 12, 2005
Last Updated:	May 19, 2008
ClinicalTrials.gov Identifier:	NCT00265200
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

Study placed in the following topic categories:

Thoracic Neoplasms

Non-small cell lung cancer

Zoledronic acid

Carcinoma, Neuroendocrine

Carcinoma

Neuroendocrine Tumors

Carcinoma, Small Cell

Neuroectodermal Tumors

Respiratory Tract Diseases

Lung Neoplasms

Lung Diseases

Neoplasms, Germ Cell and Embryonal

Neoplasm Metastasis

Neuroepithelioma

Adenocarcinoma

Carcinoma, Non-Small-Cell Lung

Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Respiratory Tract Neoplasms

Neoplastic Processes

Neoplasms

Pathologic Processes

Neoplasms by Site

Neoplasms by Histologic Type

Physiological Effects of Drugs

Neoplasms, Nerve Tissue

Bone Density Conservation Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on September 05, 2008

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