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

Phase 2TerminatedNCT00265200

University of Louisville28 enrolled

Overview

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.

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

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Carcinoma, Non-Small Cell Lung Carcinoma, Small Cell Lung Metastases

Interventions

zoledronic acidDRUG

3.0-4.0 mg by IV (in the vein), once a month for 6 months

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

James Graham Brown Cancer Center

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Average Percent Change From Baseline in TRAP Levels at 2 Weeks

Change was calculated as 100% (value at baseline minus value at 2 weeks)/value at baseline

Time frame: TRAP levels at Baseline and 2 weeks after first Zometa infusion

Data from ClinicalTrials.gov

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