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

Phase 2

Terminated

• Conditions: Metastases; Carcinoma, Non-Small Cell Lung; Carcinoma, Small Cell Lung
• Interventions: Drug: zoledronic acid

• Registration Number: NCT00265200
• Lead Sponsor: University of Louisville

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 Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-12-12
• Study First Submitted QC: 2005-12-12
• Study First Posted: 2005-12-14
• Primary Completion: 2009-08
• Study Completion: 2010-12
• Results First Submitted: 2013-04-08
• Results First Submitted QC: 2017-04-04
• Results First Posted: 2017-04-06
• Status Verified: 2018-03
• Last Update Submitted: 2018-03-01
• Last Update Posted: 2018-03-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
zoledronic acid	zoledronic acid	3.0-4.0 mg by IV (in the vein), once a month for 6 months

Primary Outcome Measures

Name	Time	Method
Average Percent Change From Baseline in TRAP Levels at 2 Weeks	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

Trial Locations

Locations (1)

James Graham Brown Cancer Center; 🇺🇸 Louisville, Kentucky, United States