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

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ClinicalTrials.gov Identifier: NCT00265200
Recruitment Status : Terminated (funding discontinued by sponsor)
First Posted : December 14, 2005
Results First Posted : April 6, 2017
Last Update Posted : March 5, 2018
Sponsor:
Collaborators:
James Graham Brown Cancer Center
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Goetz Kloecker, James Graham Brown Cancer Center

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases Drug: zoledronic acid Phase 2

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 28 participants
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
Study Start Date : February 2005
Actual Primary Completion Date : August 2009
Actual Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
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



Primary Outcome Measures :
  1. 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



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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

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
University of Louisville
James Graham Brown Cancer Center
Novartis Pharmaceuticals
Investigators
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville

Additional Information:
Responsible Party: Goetz Kloecker, Assoc Professor, 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 Posted: December 14, 2005    Key Record Dates
Results First Posted: April 6, 2017
Last Update Posted: March 5, 2018
Last Verified: March 2018

Keywords provided by Goetz Kloecker, 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, Small Cell
Carcinoma
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma, Non-Small-Cell Lung
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