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

NCT00265200 | Terminated Phase 2 Results DMC

• 2 other identifiers: 565.04BCC-LUN-04-002
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Zometa; bone metastasis; lung cancer; non-small cell lung cancer; small cell lung cancer; bone metabolic markers; tartrate resistant acid phosphatase

Outcome Measures

Primary Outcomes (1)

• 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

  TRAP levels at Baseline and 2 weeks after first Zometa infusion

Study Arms (1)

zoledronic acid

EXPERIMENTAL

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

Drug: zoledronic acid

Interventions

zoledronic acid DRUG

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

Also known as: Zometa

zoledronic acid

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• invasive lung cancer (small cell or non-small cell lung cancer)
• osteolytic bone metastasis determined by clinical exam, bone scan/XR
• age \> 18 years

You may not qualify if:

• concurrent malignancy with a second primary
• renal failure (serum creatinine \> 3mg/dl)
• pregnancy
• active rheumatoid arthritis
• intolerance to zoledronic acid

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

Location

Related Links

• James Graham Brown Cancer Center

MeSH Terms

Conditions

Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma; Neoplasm Metastasis; Lung Neoplasms

Interventions

Zoledronic Acid

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Goetz H Kloecker, MD
• Organization: James Graham Brown Cancer Center, University of Louisville

ghkloe01@louisville.edu

502-562-4358

Study Officials

• Goetz H Kloecker, MD, MSPH

  James Graham Brown Cancer Center/ University of Louisville

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc Professor

Study Record Dates

• First Submitted: December 12, 2005
• First Posted: December 14, 2005
• Study Start: February 1, 2005
• Primary Completion: August 1, 2009
• Study Completion: December 1, 2010
• Last Updated: March 5, 2018
• Results First Posted: April 6, 2017

Record last verified: 2018-03

Locations

US (1)