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

Phase 4
18 Years
Not Enrolling
Non-Small-Cell Lung Cancer, Pleural Effusion, Malignant

Thank you

Trial Information

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

Inclusion Criteria:

- Age greater than or equal to 18 years

- Histologically confirmed NSCLC (squamous cell carcinoma, adenocarcinoma, large cell

- 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

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

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

Principal Investigator

L. Lacerna, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Novartis Pharmaceuticals


United States: Institutional Review Board

Study ID:




Start Date:

November 2004

Completion Date:

November 2007

Related Keywords:

  • Non-Small-Cell Lung Cancer
  • Pleural Effusion, Malignant
  • 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
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms
  • Pleural Effusion
  • Pleural Effusion, Malignant



Southwest Regional Cancer Center Austin, Texas  78705
Summa Health System Akron, Ohio  44312
Ocala Oncology Center Ocala, Florida  34474
Louisiana Oncology Associates Lafayette, Louisiana  70506
Nevada Cancer Center Las Vegas, Nevada  89109
Front Range Cancer Specialists Fort Collins, Colorado  80528
Rocky Mountain Cancer Centers Thornton, Colorado  80260
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Oncology Alliance, S.C. Milwaukee, Wisconsin  53215
Tyler Cancer Center Tyler, Texas  75702
St. Joseph Medical Center Towson, Maryland  21204
Associates in Oncology and Hematology Chattanooga, Tennessee  37404
Maryland Hematology/Oncology Associates Baltimore, Maryland  21236
Western Washington Oncology Olympia, Washington  98502
Midwest Cancer Research Group Skokie, Illinois  60077
Sinai Hospital Baltimore, Maryland  21215
Medical Consultants, PC Muncie, Indiana  47304
Lagrange Oncology Associates La Grange, Illinois  60525
Virginia Cancer Institute Richmond, Virginia  23230
Redwood Regional Medical Group Santa Rosa, California  95403
Pasco Pinellas Cancer Center New Port Richey, Florida  34652
Space Coast Medical Titusville, Florida  32796
Hematology and Oncology Specialists New Orleans, Louisiana  70115
Bay Area Cancer Research Group Concord, California  94520
Northwest Medical Specialists Arlington Heights, Illinois  60004
The West Clinic Memphis, Tennessee  38120
Caritas Holy Family Hospital Methuen, Massachusetts  01844
Suburban Hematology-Oncology Snellville, Georgia  30078-6782
Cabrini Center for Cancer Care Alexandria, Louisiana  71301
South Texas Oncology & Hematology San Antonio, Texas  78207
Broome Oncology Johnson City, New York  13790
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Birmingham Hematology and Oncology Associates Birmingham, Alabama  35235
The Cancer Institute at Alexian Brothers Elk Grove Village, Illinois  60007
Baptist Cancer Institute Jacksonville, Florida  32207
Greeley Medical Clinic Greeley, Colorado  80631
McLeod Cancer & Blood Center Johnson City, Tennessee  37604
Henry Ford Medical Center Dearborn, Michigan  48126
Hematology-Oncology Associates of CNY East Syracuse, New York  13057
Highland Clinic, APMC Shreveport, Louisiana  71105
Hembree Cancer Center-St. Edward Mercy Medical Center Fort Smith, Arkansas  72903
Pacific Cancer Medical Center Inc. Anaheim, California  92801
Fresno Hem/Onc Medical Group Fresno, California  93720
Beaver Med Group Highland, California  92346
Stockton Hem. Onc. Stockton, California  95204
Western Hematology/Oncology Lakewood, Colorado  80215
Hematology Oncology PC Stamford, Connecticut  06902
Christiana Care Health Services Newark, Delaware  19713
Gainesville Hematology Oncology Associates Gainesville, Florida  32605
Center for Cancer Care & Research Lakeland, Florida  33805
Lake Heart & Cancer Center Leesburg, Florida  34748
Melbourne Internal Medicine Assoc (MIMA) Century Research Melbourne, Florida  32901
Mid- Florida Hematology & Oncology Centers, PA Orange City, Florida  32763
Vero Beach Hematology/Oncology Vero Beach, Florida  32960
Hematology & Oncology of N.E. GA Athens, Georgia  30607
Augusta Onc. Associates Augusta, Georgia  30901
Regional Cancer Center Danville, Illinois  61832
Lekha Babu M.D Ltd. Flossmoor, Illinois  60422
Joliet Oncology Hematology Associates, Ltd Joliet, Illinois  60435
Kentuckiana Cancer Center, PLLC Louisville, Kentucky  40202
W. Kentucky Hematology's Oncology Group, PSC Paducah, Kentucky  42003
David H. Smith, MD Chestertown, Maryland  21620
Oncology-Hematology Associates, PA Clinton, Maryland  20735
Maryland Oncology Columbia, Maryland  21044
Fallon Clinic Worcester, Massachusetts  01605
Singh & Arora Hematology/Oncology Flint, Michigan  48532
Hubert Humphrey Cancer Center Robbinsdale, Minnesota  55442
Heartland Hematology/Oncology Associates Inc. Kansas City, Missouri  64118
St. Joseph Onocology, Inc. St. Joseph, Missouri  64507
University Hematology Oncology, Inc. St. Louis, Missouri  63110
Sierra Nevada Oncology Care Carson City, Nevada  89703
US Oncology Las Vegas, Nevada  89109
Center For Cancer & Hematologic Disease Cherry Hill, New Jersey  08003
HOANNJ/Carol G. Simon Cancer Center Morristown, New Jersey  07960
Medical Hematology/Oncology Somerset, New Jersey  08873
Huntington Medical Group Huntington Station, New York  11746
Kin Yui Lam, MD New York, New York  10013
Alamance Regional Medical Ctr. Cancer Ctr. Burlington, North Carolina  27215
OHCI Cincinnati, Ohio  45242
Mukesh Bhatt, MD Medina, Ohio  44256
Lawrence M. Stallings, MD, LLC Wooster, Ohio  44691
M. Farouk Kanaa, MD, Inc. Oklahoma City, Oklahoma  73120
Cancer Treatment Center Tulsa, Oklahoma  74133
Oncology-Hematology of Lehigh Valley PC Bethlehem, Pennsylvania  18015
Paul V. Woolley MD PC Johnstown, Pennsylvania  15905
Chester County Hematology/Oncology Services West Chester, Pennsylvania  19380
South Carolina Oncology Assoc., PA Columbia, South Carolina  29201
Palmetto Hematology Oncology, P.C Spartanburg, South Carolina  29303-3041
The Family Cancer Center, PLLC Collierville, Tennessee  38017
Kingsport Hematology-Oncology Kingsport, Tennessee  37660
Eastern Connecticut Hematology/Oncology Memphis, Tennessee  38138
Oncology Hematology of South Florida Memphis, Tennessee  38138
St. Joseph Regional Cancer Ctr. Bryan, Texas  77802
Coastal Bend Cancer Center Corpus Christi, Texas  78404
Oncology Consultants P.A. Houston, Texas  77024
Cancer Outreach Abingdon, Virginia  24211
Lynchburg Oncology Lynchburg, Virginia  24501
Oncology/Hematology Association of SW VA Roanoke, Virginia  24104
Western WA Med. Grp. Oncology Everett, Washington  98201
Swedish Health Services Seattle, Washington  98104