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

University of Louisville (UOFL)

Status and phase: Terminated; Phase 2

Conditions: Carcinoma, Non-Small Cell Lung; Metastases; Carcinoma, Small Cell Lung

Treatments: Drug: zoledronic acid

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00265200

565.04

BCC-LUN-04-002 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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28 participants in 1 patient group

zoledronic acid

Experimental group

Description:

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

Treatment:

Drug: zoledronic acid