Non-small Cell Lung Cancer Registry

NCT ID: NCT00099541

Last Updated: 2009-11-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-11-30

Study Completion Date

2007-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This trial will evaluate two separate groups of patients with stage IIIB/IV non-small cell lung cancer. The objective of Group 1 is to investigate an FDA-approved drug in stage IIIB/IV non-small cell lung cancer patients that has spread to the bones. The objective of Group 2 is to see if a blood test can be used to predict when cancer-related bone lesions develop. This trial is seeking patients 18 years or older that have been diagnosed with Stage IIIB or Stage IV non-small cell lung cancer that cannot be treated by surgery.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small-Cell Lung Cancer Pleural Effusion, Malignant

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Lung Cancer Bone Metastases Bone Markers NTX zoledronic acid Registry Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC) Unresectable Stage IIIB NSCLC with Pleural Effusion

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

zoledronic acid

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Age greater than or equal to 18 years
* Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell carcinoma).
* Unresectable Stage IIIB with pleural effusion or stage IV NSCLC
* ECOG performance status of 0 or 1

Exclusion Criteria

* Patients who received an IV bisphosphonate (e.g.pamidronate; zoledronic acid)
* Patients who received an oral bisphosphonate therapy in the 6 months prior to screening (alendronate; etidronate; risedronate; tiludronate; ibandronate)
* Patients who are currently receiving any investigational drugs that are suspected to have renal toxicity and/or are excreted by the kidneys
* Known clinically significant hypersensitivity to zoledronic acid or other bisphosphonates or any of the excipients in the formulation of zoledronic acid (mannitol, sodium citrate)
* Abnormal renal function or creatinine clearance
* Unstable brain metastasis
* Women of childbearing potential not using a medically recognized form of contraception, as well as women who are breastfeeding
* Patients with nonmalignant conditions which would confound the evaluation of the primary endpoint, impair tolerance of therapy, or prevent compliance to the protocol
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

L. Lacerna, MD

Role: STUDY_CHAIR

Novartis Pharmaceuticals

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham Hematology and Oncology Associates

Birmingham, Alabama, United States

Site Status

Hembree Cancer Center-St. Edward Mercy Medical Center

Fort Smith, Arkansas, United States

Site Status

Pacific Cancer Medical Center Inc.

Anaheim, California, United States

Site Status

Bay Area Cancer Research Group

Concord, California, United States

Site Status

Fresno Hem/Onc Medical Group

Fresno, California, United States

Site Status

Beaver Med Group

Highland, California, United States

Site Status

Redwood Regional Medical Group

Santa Rosa, California, United States

Site Status

Stockton Hem. Onc.

Stockton, California, United States

Site Status

Rocky Mountain Cancer Centers

Denver, Colorado, United States

Site Status

Front Range Cancer Specialists

Fort Collins, Colorado, United States

Site Status

Greeley Medical Clinic

Greeley, Colorado, United States

Site Status

Western Hematology/Oncology

Lakewood, Colorado, United States

Site Status

Hematology Oncology PC

Stamford, Connecticut, United States

Site Status

Christiana Care Health Services

Newark, Delaware, United States

Site Status

Gainesville Hematology Oncology Associates

Gainesville, Florida, United States

Site Status

Baptist Cancer Institute

Jacksonville, Florida, United States

Site Status

Center for Cancer Care & Research

Lakeland, Florida, United States

Site Status

Lake Heart & Cancer Center

Leesburg, Florida, United States

Site Status

Melbourne Internal Medicine Assoc (MIMA) Century Research

Melbourne, Florida, United States

Site Status

Pasco Pinellas Cancer Center

New Port Richey, Florida, United States

Site Status

Ocala Oncology Center

Ocala, Florida, United States

Site Status

Mid- Florida Hematology & Oncology Centers, PA

Orange City, Florida, United States

Site Status

Space Coast Medical

Titusville, Florida, United States

Site Status

Vero Beach Hematology/Oncology

Vero Beach, Florida, United States

Site Status

Hematology & Oncology of N.E. GA

Athens, Georgia, United States

Site Status

Augusta Onc. Associates

Augusta, Georgia, United States

Site Status

Suburban Hematology-Oncology

Snellville, Georgia, United States

Site Status

Regional Cancer Center

Danville, Illinois, United States

Site Status

The Cancer Institute at Alexian Brothers

Elk Grove Village, Illinois, United States

Site Status

Lekha Babu M.D Ltd.

Flossmoor, Illinois, United States

Site Status

Joliet Oncology Hematology Associates, Ltd

Joliet, Illinois, United States

Site Status

LaGrange Oncology Associates

LaGrange, Illinois, United States

Site Status

Northwest Medical Specialists

Niles, Illinois, United States

Site Status

Midwest Cancer Research Group

Skokie, Illinois, United States

Site Status

Medical Consultants, PC

Muncie, Indiana, United States

Site Status

Kentuckiana Cancer Center, PLLC

Louisville, Kentucky, United States

Site Status

W. Kentucky Hematology's Oncology Group, PSC

Paducah, Kentucky, United States

Site Status

Cabrini Center for Cancer Care

Alexandria, Louisiana, United States

Site Status

Louisiana Oncology Associates

Lafayette, Louisiana, United States

Site Status

Hematology and Oncology Specialists

Metairie, Louisiana, United States

Site Status

Highland Clinic, APMC

Shreveport, Louisiana, United States

Site Status

Sinai Hospital

Baltimore, Maryland, United States

Site Status

Maryland Hematology/Oncology Associates

Baltimore, Maryland, United States

Site Status

David H. Smith, MD

Chestertown, Maryland, United States

Site Status

Oncology-Hematology Associates, PA

Clinton, Maryland, United States

Site Status

Maryland Oncology

Columbia, Maryland, United States

Site Status

St. Joseph Medical Center

Towson, Maryland, United States

Site Status

Caritas Holy Family Hospital

Methuen, Massachusetts, United States

Site Status

Fallon Clinic

Worcester, Massachusetts, United States

Site Status

Henry Ford Medical Center

Detroit, Michigan, United States

Site Status

Singh & Arora Hematology/Oncology

Flint, Michigan, United States

Site Status

Hubert Humphrey Cancer Center

Robbinsdale, Minnesota, United States

Site Status

Heartland Hematology/Oncology Associates Inc.

Kansas City, Missouri, United States

Site Status

St. Joseph Onocology, Inc.

Saint Joseph, Missouri, United States

Site Status

University Hematology Oncology, Inc.

St Louis, Missouri, United States

Site Status

St. John's Mercy Medical Center

St Louis, Missouri, United States

Site Status

Sierra Nevada Oncology Care

Carson City, Nevada, United States

Site Status

Nevada Cancer Center

Las Vegas, Nevada, United States

Site Status

US Oncology

Las Vegas, Nevada, United States

Site Status

Center For Cancer & Hematologic Disease

Cherry Hill, New Jersey, United States

Site Status

HOANNJ/Carol G. Simon Cancer Center

Morristown, New Jersey, United States

Site Status

Medical Hematology/Oncology

Somerset, New Jersey, United States

Site Status

Hematology-Oncology Associates of CNY

East Syracuse, New York, United States

Site Status

Huntington Medical Group

Huntington Station, New York, United States

Site Status

Broome Oncology

Johnson City, New York, United States

Site Status

Kin Yui Lam, MD

New York, New York, United States

Site Status

Alamance Regional Medical Ctr. Cancer Ctr.

Burlington, North Carolina, United States

Site Status

Raleigh Hematology Oncology Associates

Raleigh, North Carolina, United States

Site Status

Summa Health System

Akron, Ohio, United States

Site Status

OHCI

Cincinnati, Ohio, United States

Site Status

Mukesh Bhatt, MD

Medina, Ohio, United States

Site Status

Lawrence M. Stallings, MD, LLC

Wooster, Ohio, United States

Site Status

M. Farouk Kanaa, MD, Inc.

Oklahoma City, Oklahoma, United States

Site Status

Cancer Treatment Center

Tulsa, Oklahoma, United States

Site Status

Oncology-Hematology of Lehigh Valley PC

Bethlehem, Pennsylvania, United States

Site Status

Paul V. Woolley MD PC

Johnstown, Pennsylvania, United States

Site Status

Chester County Hematology/Oncology Services

West Chester, Pennsylvania, United States

Site Status

South Carolina Oncology Assoc., PA

Columbia, South Carolina, United States

Site Status

Palmetto Hematology Oncology, P.C

Spartanburg, South Carolina, United States

Site Status

Associates in Oncology and Hematology

Chattanooga, Tennessee, United States

Site Status

The Family Cancer Center, PLLC

Collierville, Tennessee, United States

Site Status

McLeod Cancer & Blood Center

Johnson City, Tennessee, United States

Site Status

Kingsport Hematology-Oncology

Kingsport, Tennessee, United States

Site Status

Eastern Connecticut Hematology/Oncology

Memphis, Tennessee, United States

Site Status

Oncology Hematology of South Florida

Memphis, Tennessee, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

Southwest Regional Cancer Center

Austin, Texas, United States

Site Status

St. Joseph Regional Cancer Ctr.

Bryan, Texas, United States

Site Status

Coastal Bend Cancer Center

Corpus Christi, Texas, United States

Site Status

Center for Oncology Research and Treatment, PA

Dallas, Texas, United States

Site Status

Oncology Consultants P.A.

Houston, Texas, United States

Site Status

South Texas Oncology & Hematology

San Antonio, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Cancer Outreach

Abingdon, Virginia, United States

Site Status

Lynchburg Oncology

Lynchburg, Virginia, United States

Site Status

Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Oncology/Hematology Association of SW VA

Roanoke, Virginia, United States

Site Status

Western WA Med. Grp. Oncology

Everett, Washington, United States

Site Status

Western Washington Oncology

Lacey, Washington, United States

Site Status

Swedish Health Services

Seattle, Washington, United States

Site Status

Oncology Alliance, S.C.

Glendale, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.novartisclinicaltrials.com

Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

US99

Identifier Type: -

Identifier Source: secondary_id

Z-NEXT

Identifier Type: -

Identifier Source: secondary_id

CZOL446EUS99

Identifier Type: -

Identifier Source: org_study_id