Non-small Cell Lung Cancer Registry

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.

Study Overview

• Status: Completed
• Conditions: Pleural Effusion, Malignant; Non-Small-Cell Lung Cancer
• Intervention / Treatment: Drug: zoledronic acid

• Study Type: Interventional
• Enrollment: 300
• Phase: Phase 4

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
Overall survival
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
Group 2: Obervational

Collaborators and Investigators

• Sponsor: Novartis Pharmaceuticals
• Investigators: Study Chair: L. Lacerna, MD, Novartis Pharmaceuticals

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Study Completion: November 1, 2007

Study Registration Dates

• First Submitted: December 15, 2004
• First Submitted That Met QC Criteria: December 15, 2004
• First Posted (Estimate): December 16, 2004

Study Record Updates

• Last Update Posted (Estimate): November 23, 2009
• Last Update Submitted That Met QC Criteria: November 20, 2009
• Last Verified: November 1, 2009

More Information

Terms related to this study

• Keywords: Lung Cancer; Registry; zoledronic acid; Bone Markers; Bone Metastases; NTX; Unresectable Stage IV Non Small-cell Lung Cancer (NSCLC); Unresectable Stage IIIB NSCLC with Pleural Effusion
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Pleural Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Pleural Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Pleural Effusion, Malignant; Pleural Effusion; Physiological Effects of Drugs; Bone Density Conservation Agents; Zoledronic Acid
• Other Study ID Numbers: CZOL446EUS99; US99; Z-NEXT