Non-small Cell Lung Cancer Registry

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00099541
First received: December 15, 2004
Last updated: November 20, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Non-Small-Cell Lung Cancer
Pleural Effusion, Malignant
Drug: zoledronic acid
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Dual-Cohort, Prospective, Observational Study of Unresectable Stage IIIB/IV Non-Small Cell Lung Cancer Patients With and Without Bone Metastasis

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
  • Group 2: Observational

Secondary Outcome Measures:
  • Patients with an SRE will be evaluated for:
  • Time from stage IIIB/IV NSCLC diagnosis to progression to bone
  • Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
  • The effect of serum NTX levels on the development of skeletal events (SREs), and
  • Overall survival
  • Group 2: Obervational

Estimated Enrollment: 300
Study Start Date: November 2004
Estimated Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00099541

  Hide Study Locations
Locations
United States, Alabama
Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States, 35205
United States, Arkansas
Hembree Cancer Center-St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States, 72903
United States, California
Pacific Cancer Medical Center Inc.
Anaheim, California, United States, 92801
Bay Area Cancer Research Group
Concord, California, United States, 94520
Fresno Hem/Onc Medical Group
Fresno, California, United States, 93720
Beaver Med Group
Highland, California, United States, 92346
Redwood Regional Medical Group
Santa Rosa, California, United States, 95403
Stockton Hem. Onc.
Stockton, California, United States, 95204
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
Front Range Cancer Specialists
Fort Collins, Colorado, United States, 80524
Greeley Medical Clinic
Greeley, Colorado, United States, 80631
Western Hematology/Oncology
Lakewood, Colorado, United States, 80215
United States, Connecticut
Hematology Oncology PC
Stamford, Connecticut, United States, 06902
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Florida
Gainesville Hematology Oncology Associates
Gainesville, Florida, United States, 32605
Baptist Cancer Institute
Jacksonville, Florida, United States, 32207
Center for Cancer Care & Research
Lakeland, Florida, United States, 33805
Lake Heart & Cancer Center
Leesburg, Florida, United States, 34748
Melbourne Internal Medicine Assoc (MIMA) Century Research
Melbourne, Florida, United States, 32901
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States, 34652
Ocala Oncology Center
Ocala, Florida, United States, 34474
Mid- Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States, 32763
Space Coast Medical
Titusville, Florida, United States, 32796
Vero Beach Hematology/Oncology
Vero Beach, Florida, United States, 32960
United States, Georgia
Hematology & Oncology of N.E. GA
Athens, Georgia, United States, 30607
Augusta Onc. Associates
Augusta, Georgia, United States, 30901
Suburban Hematology-Oncology
Snellville, Georgia, United States, 30078
United States, Illinois
Regional Cancer Center
Danville, Illinois, United States, 61832
The Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, United States, 60007
Lekha Babu M.D Ltd.
Flossmoor, Illinois, United States, 60422
Joliet Oncology Hematology Associates, Ltd
Joliet, Illinois, United States, 60435
LaGrange Oncology Associates
LaGrange, Illinois, United States, 60525
Northwest Medical Specialists
Niles, Illinois, United States, 60714
Midwest Cancer Research Group
Skokie, Illinois, United States, 60077
United States, Indiana
Medical Consultants, PC
Muncie, Indiana, United States, 47303
United States, Kentucky
Kentuckiana Cancer Center, PLLC
Louisville, Kentucky, United States, 40202
W. Kentucky Hematology's Oncology Group, PSC
Paducah, Kentucky, United States, 42003
United States, Louisiana
Cabrini Center for Cancer Care
Alexandria, Louisiana, United States, 71301
Louisiana Oncology Associates
Lafayette, Louisiana, United States, 70506
Hematology and Oncology Specialists
Metairie, Louisiana, United States, 70006
Highland Clinic, APMC
Shreveport, Louisiana, United States, 71105
United States, Maryland
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States, 21237
Sinai Hospital
Baltimore, Maryland, United States, 21215
David H. Smith, MD
Chestertown, Maryland, United States, 21620
Oncology-Hematology Associates, PA
Clinton, Maryland, United States, 20735
Maryland Oncology
Columbia, Maryland, United States, 21044
St. Joseph Medical Center
Towson, Maryland, United States, 21204
United States, Massachusetts
Caritas Holy Family Hospital
Methuen, Massachusetts, United States, 01844
Fallon Clinic
Worcester, Massachusetts, United States, 01605
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Singh & Arora Hematology/Oncology
Flint, Michigan, United States, 48532
United States, Minnesota
Hubert Humphrey Cancer Center
Robbinsdale, Minnesota, United States, 55442
United States, Missouri
Heartland Hematology/Oncology Associates Inc.
Kansas City, Missouri, United States, 64118
St. Joseph Onocology, Inc.
St. Joseph, Missouri, United States, 64507
St. John's Mercy Medical Center
St. Louis, Missouri, United States, 63141
University Hematology Oncology, Inc.
St. Louis, Missouri, United States, 63110
United States, Nevada
Sierra Nevada Oncology Care
Carson City, Nevada, United States, 89703
US Oncology
Las Vegas, Nevada, United States, 89109
Nevada Cancer Center
Las Vegas, Nevada, United States, 89109
United States, New Jersey
Center For Cancer & Hematologic Disease
Cherry Hill, New Jersey, United States, 08003
HOANNJ/Carol G. Simon Cancer Center
Morristown, New Jersey, United States, 07960
Medical Hematology/Oncology
Somerset, New Jersey, United States, 08873
United States, New York
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States, 13057
Huntington Medical Group
Huntington Station, New York, United States, 11746
Broome Oncology
Johnson City, New York, United States, 13790
Kin Yui Lam, MD
New York, New York, United States, 10013
United States, North Carolina
Alamance Regional Medical Ctr. Cancer Ctr.
Burlington, North Carolina, United States, 27215
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States, 27609
United States, Ohio
Summa Health System
Akron, Ohio, United States, 44304
OHCI
Cincinnati, Ohio, United States, 45242
Mukesh Bhatt, MD
Medina, Ohio, United States, 44256
Lawrence M. Stallings, MD, LLC
Wooster, Ohio, United States, 44691
United States, Oklahoma
M. Farouk Kanaa, MD, Inc.
Oklahoma City, Oklahoma, United States, 73120
Cancer Treatment Center
Tulsa, Oklahoma, United States, 74133
United States, Pennsylvania
Oncology-Hematology of Lehigh Valley PC
Bethlehem, Pennsylvania, United States, 18015
Paul V. Woolley MD PC
Johnstown, Pennsylvania, United States, 15905
Chester County Hematology/Oncology Services
West Chester, Pennsylvania, United States, 19380
United States, South Carolina
South Carolina Oncology Assoc., PA
Columbia, South Carolina, United States, 29201
Palmetto Hematology Oncology, P.C
Spartanburg, South Carolina, United States, 29303-3041
United States, Tennessee
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States, 37404
The Family Cancer Center, PLLC
Collierville, Tennessee, United States, 38017
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States, 37604
Kingsport Hematology-Oncology
Kingsport, Tennessee, United States, 37660
Eastern Connecticut Hematology/Oncology
Memphis, Tennessee, United States, 38138
Oncology Hematology of South Florida
Memphis, Tennessee, United States, 38138
The West Clinic
Memphis, Tennessee, United States, 38138
United States, Texas
Southwest Regional Cancer Center
Austin, Texas, United States, 78705
St. Joseph Regional Cancer Ctr.
Bryan, Texas, United States, 77802
Coastal Bend Cancer Center
Corpus Christi, Texas, United States, 78404
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States, 75230
Oncology Consultants P.A.
Houston, Texas, United States, 77024
South Texas Oncology & Hematology
San Antonio, Texas, United States, 78258
Tyler Cancer Center
Tyler, Texas, United States, 75702
United States, Virginia
Cancer Outreach
Abingdon, Virginia, United States, 24211
Lynchburg Oncology
Lynchburg, Virginia, United States, 24501
Virginia Cancer Institute
Richmond, Virginia, United States, 23230
Oncology/Hematology Association of SW VA
Roanoke, Virginia, United States, 24104
United States, Washington
Western WA Med. Grp. Oncology
Everett, Washington, United States, 98201
Western Washington Oncology
Lacey, Washington, United States, 98503
Swedish Health Services
Seattle, Washington, United States, 98104
United States, Wisconsin
Oncology Alliance, S.C.
Glendale, Wisconsin, United States, 53212
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Chair: L. Lacerna, MD Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00099541     History of Changes
Other Study ID Numbers: CZOL446EUS99, US99, Z-NEXT
Study First Received: December 15, 2004
Last Updated: November 20, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Novartis:
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

Additional relevant MeSH terms:
Carcinoma, Non-Small-Cell Lung
Lung Neoplasms
Pleural Effusion
Pleural Effusion, Malignant
Carcinoma, Bronchogenic
Bronchial Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Pleural Diseases
Pleural Neoplasms
Zoledronic acid
Bone Density Conservation Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 16, 2014