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:
Collaborators:
University of Louisville
Novartis Pharmaceuticals
Information provided by (Responsible Party):
James Graham Brown Cancer Center
ClinicalTrials.gov Identifier:
NCT00265200
First received: December 12, 2005
Last updated: April 5, 2013
Last verified: April 2013
  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: 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:


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 ]

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
No publications provided

Responsible Party: 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 5, 2013
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, Small Cell
Lung Neoplasms
Neoplasm Metastasis
Neoplasms, Second Primary
Carcinoma
Carcinoma, Non-Small-Cell Lung
Small Cell Lung Carcinoma
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Neoplastic Processes
Pathologic Processes
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Carcinoma, Bronchogenic
Bronchial Neoplasms
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 30, 2014