Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
300 participants
INTERVENTIONAL
2004-11-30
2007-11-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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zoledronic acid
Eligibility Criteria
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Inclusion Criteria
* 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 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
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Principal Investigators
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L. Lacerna, MD
Role: STUDY_CHAIR
Novartis Pharmaceuticals
Locations
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Birmingham Hematology and Oncology Associates
Birmingham, Alabama, United States
Hembree Cancer Center-St. Edward Mercy Medical Center
Fort Smith, Arkansas, United States
Pacific Cancer Medical Center Inc.
Anaheim, California, United States
Bay Area Cancer Research Group
Concord, California, United States
Fresno Hem/Onc Medical Group
Fresno, California, United States
Beaver Med Group
Highland, California, United States
Redwood Regional Medical Group
Santa Rosa, California, United States
Stockton Hem. Onc.
Stockton, California, United States
Rocky Mountain Cancer Centers
Denver, Colorado, United States
Front Range Cancer Specialists
Fort Collins, Colorado, United States
Greeley Medical Clinic
Greeley, Colorado, United States
Western Hematology/Oncology
Lakewood, Colorado, United States
Hematology Oncology PC
Stamford, Connecticut, United States
Christiana Care Health Services
Newark, Delaware, United States
Gainesville Hematology Oncology Associates
Gainesville, Florida, United States
Baptist Cancer Institute
Jacksonville, Florida, United States
Center for Cancer Care & Research
Lakeland, Florida, United States
Lake Heart & Cancer Center
Leesburg, Florida, United States
Melbourne Internal Medicine Assoc (MIMA) Century Research
Melbourne, Florida, United States
Pasco Pinellas Cancer Center
New Port Richey, Florida, United States
Ocala Oncology Center
Ocala, Florida, United States
Mid- Florida Hematology & Oncology Centers, PA
Orange City, Florida, United States
Space Coast Medical
Titusville, Florida, United States
Vero Beach Hematology/Oncology
Vero Beach, Florida, United States
Hematology & Oncology of N.E. GA
Athens, Georgia, United States
Augusta Onc. Associates
Augusta, Georgia, United States
Suburban Hematology-Oncology
Snellville, Georgia, United States
Regional Cancer Center
Danville, Illinois, United States
The Cancer Institute at Alexian Brothers
Elk Grove Village, Illinois, United States
Lekha Babu M.D Ltd.
Flossmoor, Illinois, United States
Joliet Oncology Hematology Associates, Ltd
Joliet, Illinois, United States
LaGrange Oncology Associates
LaGrange, Illinois, United States
Northwest Medical Specialists
Niles, Illinois, United States
Midwest Cancer Research Group
Skokie, Illinois, United States
Medical Consultants, PC
Muncie, Indiana, United States
Kentuckiana Cancer Center, PLLC
Louisville, Kentucky, United States
W. Kentucky Hematology's Oncology Group, PSC
Paducah, Kentucky, United States
Cabrini Center for Cancer Care
Alexandria, Louisiana, United States
Louisiana Oncology Associates
Lafayette, Louisiana, United States
Hematology and Oncology Specialists
Metairie, Louisiana, United States
Highland Clinic, APMC
Shreveport, Louisiana, United States
Sinai Hospital
Baltimore, Maryland, United States
Maryland Hematology/Oncology Associates
Baltimore, Maryland, United States
David H. Smith, MD
Chestertown, Maryland, United States
Oncology-Hematology Associates, PA
Clinton, Maryland, United States
Maryland Oncology
Columbia, Maryland, United States
St. Joseph Medical Center
Towson, Maryland, United States
Caritas Holy Family Hospital
Methuen, Massachusetts, United States
Fallon Clinic
Worcester, Massachusetts, United States
Henry Ford Medical Center
Detroit, Michigan, United States
Singh & Arora Hematology/Oncology
Flint, Michigan, United States
Hubert Humphrey Cancer Center
Robbinsdale, Minnesota, United States
Heartland Hematology/Oncology Associates Inc.
Kansas City, Missouri, United States
St. Joseph Onocology, Inc.
Saint Joseph, Missouri, United States
University Hematology Oncology, Inc.
St Louis, Missouri, United States
St. John's Mercy Medical Center
St Louis, Missouri, United States
Sierra Nevada Oncology Care
Carson City, Nevada, United States
Nevada Cancer Center
Las Vegas, Nevada, United States
US Oncology
Las Vegas, Nevada, United States
Center For Cancer & Hematologic Disease
Cherry Hill, New Jersey, United States
HOANNJ/Carol G. Simon Cancer Center
Morristown, New Jersey, United States
Medical Hematology/Oncology
Somerset, New Jersey, United States
Hematology-Oncology Associates of CNY
East Syracuse, New York, United States
Huntington Medical Group
Huntington Station, New York, United States
Broome Oncology
Johnson City, New York, United States
Kin Yui Lam, MD
New York, New York, United States
Alamance Regional Medical Ctr. Cancer Ctr.
Burlington, North Carolina, United States
Raleigh Hematology Oncology Associates
Raleigh, North Carolina, United States
Summa Health System
Akron, Ohio, United States
OHCI
Cincinnati, Ohio, United States
Mukesh Bhatt, MD
Medina, Ohio, United States
Lawrence M. Stallings, MD, LLC
Wooster, Ohio, United States
M. Farouk Kanaa, MD, Inc.
Oklahoma City, Oklahoma, United States
Cancer Treatment Center
Tulsa, Oklahoma, United States
Oncology-Hematology of Lehigh Valley PC
Bethlehem, Pennsylvania, United States
Paul V. Woolley MD PC
Johnstown, Pennsylvania, United States
Chester County Hematology/Oncology Services
West Chester, Pennsylvania, United States
South Carolina Oncology Assoc., PA
Columbia, South Carolina, United States
Palmetto Hematology Oncology, P.C
Spartanburg, South Carolina, United States
Associates in Oncology and Hematology
Chattanooga, Tennessee, United States
The Family Cancer Center, PLLC
Collierville, Tennessee, United States
McLeod Cancer & Blood Center
Johnson City, Tennessee, United States
Kingsport Hematology-Oncology
Kingsport, Tennessee, United States
Eastern Connecticut Hematology/Oncology
Memphis, Tennessee, United States
Oncology Hematology of South Florida
Memphis, Tennessee, United States
The West Clinic
Memphis, Tennessee, United States
Southwest Regional Cancer Center
Austin, Texas, United States
St. Joseph Regional Cancer Ctr.
Bryan, Texas, United States
Coastal Bend Cancer Center
Corpus Christi, Texas, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas, United States
Oncology Consultants P.A.
Houston, Texas, United States
South Texas Oncology & Hematology
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, United States
Cancer Outreach
Abingdon, Virginia, United States
Lynchburg Oncology
Lynchburg, Virginia, United States
Virginia Cancer Institute
Richmond, Virginia, United States
Oncology/Hematology Association of SW VA
Roanoke, Virginia, United States
Western WA Med. Grp. Oncology
Everett, Washington, United States
Western Washington Oncology
Lacey, Washington, United States
Swedish Health Services
Seattle, Washington, United States
Oncology Alliance, S.C.
Glendale, Wisconsin, United States
Countries
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Related Links
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Visit NovartisClinicalTrials.com: Pre-qualify for a trial, and view a list of trials and participating study centers.
Other Identifiers
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US99
Identifier Type: -
Identifier Source: secondary_id
Z-NEXT
Identifier Type: -
Identifier Source: secondary_id
CZOL446EUS99
Identifier Type: -
Identifier Source: org_study_id