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Non-Small-Cell Lung CancerPhase 4NCT00099541

Non-small Cell Lung Cancer Registry

A Phase 4 study testing zoledronic acid in people with Non-Small-Cell Lung Cancer and Pleural Effusion, Malignant, run by Novartis Pharmaceuticals at 101 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
zoledronic acid
How many people
300 participants
Where
101 sitesUnited States
Study dates
Nov 2004to Nov 2007
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

101 sites in 1 country.

101 sites in 1 country

United States101 sites

  • Cancer Outreach

    Abingdon, Virginia, 24211

  • Summa Health System

    Akron, Ohio, 44304

  • Cabrini Center for Cancer Care

    Alexandria, Louisiana, 71301

  • Pacific Cancer Medical Center Inc.

    Anaheim, California, 92801

  • Hematology & Oncology of N.E. GA

    Athens, Georgia, 30607

  • Augusta Onc. Associates

    Augusta, Georgia, 30901

  • Southwest Regional Cancer Center

    Austin, Texas, 78705

  • Sinai Hospital

    Baltimore, Maryland, 21215

  • Maryland Hematology/Oncology Associates

    Baltimore, Maryland, 21237

  • Oncology-Hematology of Lehigh Valley PC

    Bethlehem, Pennsylvania, 18015

  • Birmingham Hematology and Oncology Associates

    Birmingham, Alabama, 35205

  • St. Joseph Regional Cancer Ctr.

    Bryan, Texas, 77802

  • Alamance Regional Medical Ctr. Cancer Ctr.

    Burlington, North Carolina, 27215

  • Sierra Nevada Oncology Care

    Carson City, Nevada, 89703

  • Associates in Oncology and Hematology

    Chattanooga, Tennessee, 37404

  • Center For Cancer & Hematologic Disease

    Cherry Hill, New Jersey, 08003

  • David H. Smith, MD

    Chestertown, Maryland, 21620

  • OHCI

    Cincinnati, Ohio, 45242

  • Oncology-Hematology Associates, PA

    Clinton, Maryland, 20735

  • The Family Cancer Center, PLLC

    Collierville, Tennessee, 38017

  • Maryland Oncology

    Columbia, Maryland, 21044

  • South Carolina Oncology Assoc., PA

    Columbia, South Carolina, 29201

  • Bay Area Cancer Research Group

    Concord, California, 94520

  • Coastal Bend Cancer Center

    Corpus Christi, Texas, 78404

  • Center for Oncology Research and Treatment, PA

    Dallas, Texas, 75230

  • Regional Cancer Center

    Danville, Illinois, 61832

  • Rocky Mountain Cancer Centers

    Denver, Colorado, 80218

  • Henry Ford Medical Center

    Detroit, Michigan, 48202

  • Hematology-Oncology Associates of CNY

    East Syracuse, New York, 13057

  • The Cancer Institute at Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • Western WA Med. Grp. Oncology

    Everett, Washington, 98201

  • Singh & Arora Hematology/Oncology

    Flint, Michigan, 48532

  • Lekha Babu M.D Ltd.

    Flossmoor, Illinois, 60422

  • Front Range Cancer Specialists

    Fort Collins, Colorado, 80524

  • Hembree Cancer Center-St. Edward Mercy Medical Center

    Fort Smith, Arkansas, 72903

  • Fresno Hem/Onc Medical Group

    Fresno, California, 93720

  • Gainesville Hematology Oncology Associates

    Gainesville, Florida, 32605

  • Oncology Alliance, S.C.

    Glendale, Wisconsin, 53212

  • Greeley Medical Clinic

    Greeley, Colorado, 80631

  • Beaver Med Group

    Highland, California, 92346

  • Oncology Consultants P.A.

    Houston, Texas, 77024

  • Huntington Medical Group

    Huntington Station, New York, 11746

  • Baptist Cancer Institute

    Jacksonville, Florida, 32207

  • Broome Oncology

    Johnson City, New York, 13790

  • McLeod Cancer & Blood Center

    Johnson City, Tennessee, 37604

  • Paul V. Woolley MD PC

    Johnstown, Pennsylvania, 15905

  • Joliet Oncology Hematology Associates, Ltd

    Joliet, Illinois, 60435

  • Heartland Hematology/Oncology Associates Inc.

    Kansas City, Missouri, 64118

  • Kingsport Hematology-Oncology

    Kingsport, Tennessee, 37660

  • Western Washington Oncology

    Lacey, Washington, 98503

  • Louisiana Oncology Associates

    Lafayette, Louisiana, 70506

  • LaGrange Oncology Associates

    LaGrange, Illinois, 60525

  • Center for Cancer Care & Research

    Lakeland, Florida, 33805

  • Western Hematology/Oncology

    Lakewood, Colorado, 80215

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • US Oncology

    Las Vegas, Nevada, 89109

  • Lake Heart & Cancer Center

    Leesburg, Florida, 34748

  • Kentuckiana Cancer Center, PLLC

    Louisville, Kentucky, 40202

  • Lynchburg Oncology

    Lynchburg, Virginia, 24501

  • Mukesh Bhatt, MD

    Medina, Ohio, 44256

  • Melbourne Internal Medicine Assoc (MIMA) Century Research

    Melbourne, Florida, 32901

  • Eastern Connecticut Hematology/Oncology

    Memphis, Tennessee, 38138

  • Oncology Hematology of South Florida

    Memphis, Tennessee, 38138

  • The West Clinic

    Memphis, Tennessee, 38138

  • Hematology and Oncology Specialists

    Metairie, Louisiana, 70006

  • Caritas Holy Family Hospital

    Methuen, Massachusetts, 01844

  • HOANNJ/Carol G. Simon Cancer Center

    Morristown, New Jersey, 07960

  • Medical Consultants, PC

    Muncie, Indiana, 47303

  • Pasco Pinellas Cancer Center

    New Port Richey, Florida, 34652

  • Kin Yui Lam, MD

    New York, New York, 10013

  • Christiana Care Health Services

    Newark, Delaware, 19713

  • Northwest Medical Specialists

    Niles, Illinois, 60714

  • Ocala Oncology Center

    Ocala, Florida, 34474

  • M. Farouk Kanaa, MD, Inc.

    Oklahoma City, Oklahoma, 73120

  • Mid- Florida Hematology & Oncology Centers, PA

    Orange City, Florida, 32763

  • W. Kentucky Hematology's Oncology Group, PSC

    Paducah, Kentucky, 42003

  • Raleigh Hematology Oncology Associates

    Raleigh, North Carolina, 27609

  • Virginia Cancer Institute

    Richmond, Virginia, 23230

  • Oncology/Hematology Association of SW VA

    Roanoke, Virginia, 24104

  • Hubert Humphrey Cancer Center

    Robbinsdale, Minnesota, 55442

  • St. Joseph Onocology, Inc.

    Saint Joseph, Missouri, 64507

  • South Texas Oncology & Hematology

    San Antonio, Texas, 78258

  • Redwood Regional Medical Group

    Santa Rosa, California, 95403

  • Swedish Health Services

    Seattle, Washington, 98104

  • Highland Clinic, APMC

    Shreveport, Louisiana, 71105

  • Midwest Cancer Research Group

    Skokie, Illinois, 60077

  • Suburban Hematology-Oncology

    Snellville, Georgia, 30078

  • Medical Hematology/Oncology

    Somerset, New Jersey, 08873

  • Palmetto Hematology Oncology, P.C

    Spartanburg, South Carolina, 29303-3041

  • University Hematology Oncology, Inc.

    St Louis, Missouri, 63110

  • St. John's Mercy Medical Center

    St Louis, Missouri, 63141

  • Hematology Oncology PC

    Stamford, Connecticut, 06902

  • Stockton Hem. Onc.

    Stockton, California, 95204

  • Space Coast Medical

    Titusville, Florida, 32796

  • St. Joseph Medical Center

    Towson, Maryland, 21204

  • Cancer Treatment Center

    Tulsa, Oklahoma, 74133

  • Tyler Cancer Center

    Tyler, Texas, 75702

  • Vero Beach Hematology/Oncology

    Vero Beach, Florida, 32960

  • Chester County Hematology/Oncology Services

    West Chester, Pennsylvania, 19380

  • Lawrence M. Stallings, MD, LLC

    Wooster, Ohio, 44691

  • Fallon Clinic

    Worcester, Massachusetts, 01605

Other trials in United States

About this study

Official title: A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

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.

Being tested
zoledronic acid
Keywords
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
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Pleural Effusion, Malignant, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • zoledronic acidDrug

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases

  2. Group 2: Observational

Secondary outcomes (6)

  1. Patients with an SRE will be evaluated for:

  2. Time from stage IIIB/IV NSCLC diagnosis to progression to bone

  3. Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications

  4. The effect of serum NTX levels on the development of skeletal events (SREs), and

  5. Overall survival

  6. Group 2: Obervational

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Dec 2004 (estimated)
  2. Study startNov 2004
  3. Study completionNov 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
300 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00099541
Sponsor's protocol ID
CZOL446EUS99
Other IDs
US99, Z-NEXT
Status last verified
Nov 2009
First submitted
15 Dec 2004
Last updated
23 Nov 2009
Results posted
No

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