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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
N/A
Not Enrolling
Both
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
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

Type of Study:

Interventional

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

Authority:

United States: Institutional Review Board

Study ID:

CZOL446EUS99

NCT ID:

NCT00099541

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

Name

Location

Southwest Regional Cancer CenterAustin, Texas  78705
Summa Health SystemAkron, Ohio  44312
Ocala Oncology CenterOcala, Florida  34474
Louisiana Oncology AssociatesLafayette, Louisiana  70506
Nevada Cancer CenterLas Vegas, Nevada  89109
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Rocky Mountain Cancer CentersThornton, Colorado  80260
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Oncology Alliance, S.C.Milwaukee, Wisconsin  53215
Tyler Cancer CenterTyler, Texas  75702
St. Joseph Medical CenterTowson, Maryland  21204
Associates in Oncology and HematologyChattanooga, Tennessee  37404
Maryland Hematology/Oncology AssociatesBaltimore, Maryland  21236
Western Washington OncologyOlympia, Washington  98502
Midwest Cancer Research GroupSkokie, Illinois  60077
Sinai HospitalBaltimore, Maryland  21215
Medical Consultants, PCMuncie, Indiana  47304
Lagrange Oncology AssociatesLa Grange, Illinois  60525
Virginia Cancer InstituteRichmond, Virginia  23230
Redwood Regional Medical GroupSanta Rosa, California  95403
Pasco Pinellas Cancer CenterNew Port Richey, Florida  34652
Space Coast MedicalTitusville, Florida  32796
Hematology and Oncology SpecialistsNew Orleans, Louisiana  70115
Bay Area Cancer Research GroupConcord, California  94520
Northwest Medical SpecialistsArlington Heights, Illinois  60004
The West ClinicMemphis, Tennessee  38120
Caritas Holy Family HospitalMethuen, Massachusetts  01844
Suburban Hematology-OncologySnellville, Georgia  30078-6782
Cabrini Center for Cancer CareAlexandria, Louisiana  71301
South Texas Oncology & HematologySan Antonio, Texas  78207
Broome OncologyJohnson City, New York  13790
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Center for Oncology Research and Treatment, PADallas, Texas  75230
Birmingham Hematology and Oncology AssociatesBirmingham, Alabama  35235
The Cancer Institute at Alexian BrothersElk Grove Village, Illinois  60007
Baptist Cancer InstituteJacksonville, Florida  32207
Greeley Medical ClinicGreeley, Colorado  80631
McLeod Cancer & Blood CenterJohnson City, Tennessee  37604
Henry Ford Medical CenterDearborn, Michigan  48126
Hematology-Oncology Associates of CNYEast Syracuse, New York  13057
Highland Clinic, APMCShreveport, Louisiana  71105
Hembree Cancer Center-St. Edward Mercy Medical CenterFort Smith, Arkansas  72903
Pacific Cancer Medical Center Inc.Anaheim, California  92801
Fresno Hem/Onc Medical GroupFresno, California  93720
Beaver Med GroupHighland, California  92346
Stockton Hem. Onc.Stockton, California  95204
Western Hematology/OncologyLakewood, Colorado  80215
Hematology Oncology PCStamford, Connecticut  06902
Christiana Care Health ServicesNewark, Delaware  19713
Gainesville Hematology Oncology AssociatesGainesville, Florida  32605
Center for Cancer Care & ResearchLakeland, Florida  33805
Lake Heart & Cancer CenterLeesburg, Florida  34748
Melbourne Internal Medicine Assoc (MIMA) Century ResearchMelbourne, Florida  32901
Mid- Florida Hematology & Oncology Centers, PAOrange City, Florida  32763
Vero Beach Hematology/OncologyVero Beach, Florida  32960
Hematology & Oncology of N.E. GAAthens, Georgia  30607
Augusta Onc. AssociatesAugusta, Georgia  30901
Regional Cancer CenterDanville, Illinois  61832
Lekha Babu M.D Ltd.Flossmoor, Illinois  60422
Joliet Oncology Hematology Associates, LtdJoliet, Illinois  60435
Kentuckiana Cancer Center, PLLCLouisville, Kentucky  40202
W. Kentucky Hematology's Oncology Group, PSCPaducah, Kentucky  42003
David H. Smith, MDChestertown, Maryland  21620
Oncology-Hematology Associates, PAClinton, Maryland  20735
Maryland OncologyColumbia, Maryland  21044
Fallon ClinicWorcester, Massachusetts  01605
Singh & Arora Hematology/OncologyFlint, Michigan  48532
Hubert Humphrey Cancer CenterRobbinsdale, 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 CareCarson City, Nevada  89703
US OncologyLas Vegas, Nevada  89109
Center For Cancer & Hematologic DiseaseCherry Hill, New Jersey  08003
HOANNJ/Carol G. Simon Cancer CenterMorristown, New Jersey  07960
Medical Hematology/OncologySomerset, New Jersey  08873
Huntington Medical GroupHuntington Station, New York  11746
Kin Yui Lam, MDNew York, New York  10013
Alamance Regional Medical Ctr. Cancer Ctr.Burlington, North Carolina  27215
OHCICincinnati, Ohio  45242
Mukesh Bhatt, MDMedina, Ohio  44256
Lawrence M. Stallings, MD, LLCWooster, Ohio  44691
M. Farouk Kanaa, MD, Inc.Oklahoma City, Oklahoma  73120
Cancer Treatment CenterTulsa, Oklahoma  74133
Oncology-Hematology of Lehigh Valley PCBethlehem, Pennsylvania  18015
Paul V. Woolley MD PCJohnstown, Pennsylvania  15905
Chester County Hematology/Oncology ServicesWest Chester, Pennsylvania  19380
South Carolina Oncology Assoc., PAColumbia, South Carolina  29201
Palmetto Hematology Oncology, P.CSpartanburg, South Carolina  29303-3041
The Family Cancer Center, PLLCCollierville, Tennessee  38017
Kingsport Hematology-OncologyKingsport, Tennessee  37660
Eastern Connecticut Hematology/OncologyMemphis, Tennessee  38138
Oncology Hematology of South FloridaMemphis, Tennessee  38138
St. Joseph Regional Cancer Ctr.Bryan, Texas  77802
Coastal Bend Cancer CenterCorpus Christi, Texas  78404
Oncology Consultants P.A.Houston, Texas  77024
Cancer OutreachAbingdon, Virginia  24211
Lynchburg OncologyLynchburg, Virginia  24501
Oncology/Hematology Association of SW VARoanoke, Virginia  24104
Western WA Med. Grp. OncologyEverett, Washington  98201
Swedish Health ServicesSeattle, Washington  98104