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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

Tracking Information
First Submitted Date  ICMJE December 12, 2005
First Posted Date  ICMJE December 14, 2005
Results First Submitted Date  ICMJE April 8, 2013
Results First Posted Date  ICMJE April 6, 2017
Last Update Posted Date March 5, 2018
Study Start Date  ICMJE February 2005
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 4, 2017)
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
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2005)
TRAP level measured at baseline, week 2/4/6, month 2/3/4/5/6
Change History Complete list of historical versions of study NCT00265200 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2005)
  • Brief Pain Inventory at baseline & month 3
  • Bone imaging at baseline, month 4, & as clinically indicated
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Using TRAP to Evaluate the Effect of Zometa on Bone Metastasis Due to Lung Cancer
Official Title  ICMJE Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Carcinoma, Non-Small Cell Lung
  • Carcinoma, Small Cell Lung
  • Metastases
Intervention  ICMJE Drug: zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Other Name: Zometa
Study Arms  ICMJE Experimental: zoledronic acid
3.0-4.0 mg by IV (in the vein), once a month for 6 months
Intervention: Drug: zoledronic acid
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: January 11, 2010)
28
Original Enrollment  ICMJE
 (submitted: December 12, 2005)
40
Actual Study Completion Date  ICMJE December 2010
Actual Primary Completion Date August 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00265200
Other Study ID Numbers  ICMJE 565.04
BCC-LUN-04-002 ( Other Identifier: James Graham Brown Cancer Center Clinical Trials Office )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Goetz Kloecker, James Graham Brown Cancer Center
Study Sponsor  ICMJE University of Louisville
Collaborators  ICMJE
  • James Graham Brown Cancer Center
  • Novartis Pharmaceuticals
Investigators  ICMJE
Principal Investigator: Goetz H Kloecker, MD, MSPH James Graham Brown Cancer Center/ University of Louisville
PRS Account University of Louisville
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP