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Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Carcinoma, Non-Small Cell Lung, Carcinoma, Small Cell Lung, Metastases

Thank you

Trial Information

Bone Metabolic Markers, TRAP, and Zometa's Effect on Bone Metastasis Due to Lung Cancer


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Blood specimens to measure TRAP level

Outcome Time Frame:

baseline, every 2 weeks for 6 weeks after the first Zometa infusion, then monthly until progression of bone metastatic disease

Safety Issue:

No

Principal Investigator

Goetz H Kloecker, MD, MSPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

James Graham Brown Cancer Center/ University of Louisville

Authority:

United States: Food and Drug Administration

Study ID:

565.04

NCT ID:

NCT00265200

Start Date:

February 2005

Completion Date:

December 2010

Related Keywords:

  • Carcinoma, Non-Small Cell Lung
  • Carcinoma, Small Cell Lung
  • Metastases
  • Zometa
  • bone metastasis
  • lung cancer
  • non-small cell lung cancer
  • small cell lung cancer
  • bone metabolic markers
  • tartrate resistant acid phosphatase
  • 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

Name

Location
James Graham Brown Cancer Center Louisville, Kentucky  40202