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

This study has been terminated.

( funding discontinued by sponsor )

First Received on December 12, 2005. Last Updated on April 13, 2011 History of Changes

Sponsor:	James Graham Brown Cancer Center
Collaborators:	University of Louisville Novartis Pharmaceuticals
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:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic
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 ]

Enrollment:	28
Study Start Date:	February 2005
Study Completion Date:	December 2010
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: zoledronic acid	Drug: zoledronic acid 3.0-4.0 mg by IV (in the vein), once a month for 6 months Other Name: Zometa

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

Locations

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

Sponsors and Collaborators

James Graham Brown Cancer Center

University of Louisville

Novartis Pharmaceuticals

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:	Goetz H. Kloecker, MD, James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:	NCT00265200 History of Changes
Other Study ID Numbers:	565.04, BCC-LUN-04-002
Study First Received:	December 12, 2005
Last Updated:	April 13, 2011
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:

Carcinoma
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Small Cell Lung Carcinoma
Bone Neoplasms
Bone Marrow Diseases
Carcinoma, Small Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms

Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Bone Diseases
Musculoskeletal Diseases
Hematologic Diseases
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 12, 2012