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

This study has been terminated.
(funding discontinued by sponsor)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00265200
First Posted: December 14, 2005
Last Update Posted: April 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
University of Louisville
Novartis Pharmaceuticals
Information provided by (Responsible Party):
James Graham Brown Cancer Center
  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 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (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:


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

Primary Outcome Measures:
  • Average Percent Change From Baseline in TRAP Levels at 2 Weeks [ Time Frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion ]
    Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline


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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: James Graham Brown Cancer Center
ClinicalTrials.gov Identifier: NCT00265200     History of Changes
Other Study ID Numbers: 565.04
BCC-LUN-04-002 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
First Submitted: December 12, 2005
First Posted: December 14, 2005
Results First Submitted: April 8, 2013
Results First Posted: April 6, 2017
Last Update Posted: April 6, 2017
Last Verified: April 2017

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
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Non-Small-Cell Lung
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Carcinoma, Bronchogenic
Bronchial Neoplasms
Zoledronic acid
Diphosphonates
Bone Density Conservation Agents
Physiological Effects of Drugs