Non-small Cell Lung Cancer Registry
- Conditions
- Non-Small-Cell Lung CancerPleural Effusion, Malignant
- Registration Number
- NCT00099541
- Lead Sponsor
- Novartis Pharmaceuticals
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 300
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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
Name Time Method 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
Trial Locations
- Locations (101)
Hembree Cancer Center-St. Edward Mercy Medical Center
🇺🇸Fort Smith, Arkansas, United States
Gainesville Hematology Oncology Associates
🇺🇸Gainesville, Florida, United States
Center for Cancer Care & Research
🇺🇸Lakeland, Florida, United States
Highland Clinic, APMC
🇺🇸Shreveport, Louisiana, United States
Hematology and Oncology Specialists
🇺🇸Metairie, Louisiana, United States
Lake Heart & Cancer Center
🇺🇸Leesburg, Florida, United States
Caritas Holy Family Hospital
🇺🇸Methuen, Massachusetts, United States
Sierra Nevada Oncology Care
🇺🇸Carson City, Nevada, United States
Louisiana Oncology Associates
🇺🇸Lafayette, Louisiana, United States
Singh & Arora Hematology/Oncology
🇺🇸Flint, Michigan, United States
Maryland Oncology
🇺🇸Columbia, Maryland, United States
Oncology-Hematology Associates, PA
🇺🇸Clinton, Maryland, United States
St. Joseph Medical Center
🇺🇸Towson, Maryland, United States
Fallon Clinic
🇺🇸Worcester, Massachusetts, United States
Center For Cancer & Hematologic Disease
🇺🇸Cherry Hill, New Jersey, United States
Oncology Hematology of South Florida
🇺🇸Memphis, Tennessee, United States
Medical Hematology/Oncology
🇺🇸Somerset, New Jersey, United States
Oncology Consultants P.A.
🇺🇸Houston, Texas, United States
Swedish Health Services
🇺🇸Seattle, Washington, United States
Bay Area Cancer Research Group
🇺🇸Concord, California, United States
Stockton Hem. Onc.
🇺🇸Stockton, California, United States
Kentuckiana Cancer Center, PLLC
🇺🇸Louisville, Kentucky, United States
Suburban Hematology-Oncology
🇺🇸Snellville, Georgia, United States
Baptist Cancer Institute
🇺🇸Jacksonville, Florida, United States
Hematology Oncology PC
🇺🇸Stamford, Connecticut, United States
W. Kentucky Hematology's Oncology Group, PSC
🇺🇸Paducah, Kentucky, United States
Joliet Oncology Hematology Associates, Ltd
🇺🇸Joliet, Illinois, United States
Northwest Medical Specialists
🇺🇸Niles, Illinois, United States
Pasco Pinellas Cancer Center
🇺🇸New Port Richey, Florida, United States
Mid- Florida Hematology & Oncology Centers, PA
🇺🇸Orange City, Florida, United States
Christiana Care Health Services
🇺🇸Newark, Delaware, United States
Midwest Cancer Research Group
🇺🇸Skokie, Illinois, United States
Fresno Hem/Onc Medical Group
🇺🇸Fresno, California, United States
University Hematology Oncology, Inc.
🇺🇸St. Louis, Missouri, United States
Heartland Hematology/Oncology Associates Inc.
🇺🇸Kansas City, Missouri, United States
Hubert Humphrey Cancer Center
🇺🇸Robbinsdale, Minnesota, United States
Lekha Babu M.D Ltd.
🇺🇸Flossmoor, Illinois, United States
Cabrini Center for Cancer Care
🇺🇸Alexandria, Louisiana, United States
LaGrange Oncology Associates
🇺🇸LaGrange, Illinois, United States
Beaver Med Group
🇺🇸Highland, California, United States
Redwood Regional Medical Group
🇺🇸Santa Rosa, California, United States
Pacific Cancer Medical Center Inc.
🇺🇸Anaheim, California, United States
Augusta Onc. Associates
🇺🇸Augusta, Georgia, United States
Sinai Hospital
🇺🇸Baltimore, Maryland, United States
The Cancer Institute at Alexian Brothers
🇺🇸Elk Grove Village, Illinois, United States
Maryland Hematology/Oncology Associates
🇺🇸Baltimore, Maryland, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
St. Joseph Onocology, Inc.
🇺🇸St. Joseph, Missouri, United States
Summa Health System
🇺🇸Akron, Ohio, United States
David H. Smith, MD
🇺🇸Chestertown, Maryland, United States
Broome Oncology
🇺🇸Johnson City, New York, United States
Kin Yui Lam, MD
🇺🇸New York, New York, United States
OHCI
🇺🇸Cincinnati, Ohio, United States
Raleigh Hematology Oncology Associates
🇺🇸Raleigh, North Carolina, United States
Nevada Cancer Center
🇺🇸Las Vegas, Nevada, United States
US Oncology
🇺🇸Las Vegas, Nevada, United States
Hematology & Oncology of N.E. GA
🇺🇸Athens, Georgia, United States
Regional Cancer Center
🇺🇸Danville, Illinois, United States
Medical Consultants, PC
🇺🇸Muncie, Indiana, United States
Greeley Medical Clinic
🇺🇸Greeley, Colorado, United States
Front Range Cancer Specialists
🇺🇸Fort Collins, Colorado, United States
Western Hematology/Oncology
🇺🇸Lakewood, Colorado, United States
Henry Ford Medical Center
🇺🇸Detroit, Michigan, United States
M. Farouk Kanaa, MD, Inc.
🇺🇸Oklahoma City, Oklahoma, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
Birmingham Hematology and Oncology Associates
🇺🇸Birmingham, Alabama, United States
Ocala Oncology Center
🇺🇸Ocala, Florida, United States
Melbourne Internal Medicine Assoc (MIMA) Century Research
🇺🇸Melbourne, Florida, United States
Vero Beach Hematology/Oncology
🇺🇸Vero Beach, Florida, United States
HOANNJ/Carol G. Simon Cancer Center
🇺🇸Morristown, New Jersey, United States
Hematology-Oncology Associates of CNY
🇺🇸East Syracuse, New York, United States
Huntington Medical Group
🇺🇸Huntington Station, New York, United States
Alamance Regional Medical Ctr. Cancer Ctr.
🇺🇸Burlington, North Carolina, United States
Mukesh Bhatt, MD
🇺🇸Medina, Ohio, United States
Cancer Treatment Center
🇺🇸Tulsa, Oklahoma, United States
Lawrence M. Stallings, MD, LLC
🇺🇸Wooster, Ohio, United States
Paul V. Woolley MD PC
🇺🇸Johnstown, Pennsylvania, United States
Chester County Hematology/Oncology Services
🇺🇸West Chester, Pennsylvania, United States
The Family Cancer Center, PLLC
🇺🇸Collierville, Tennessee, United States
Oncology-Hematology of Lehigh Valley PC
🇺🇸Bethlehem, Pennsylvania, United States
South Carolina Oncology Assoc., PA
🇺🇸Columbia, South Carolina, United States
Associates in Oncology and Hematology
🇺🇸Chattanooga, Tennessee, United States
McLeod Cancer & Blood Center
🇺🇸Johnson City, Tennessee, United States
Eastern Connecticut Hematology/Oncology
🇺🇸Memphis, Tennessee, United States
Palmetto Hematology Oncology, P.C
🇺🇸Spartanburg, South Carolina, United States
Kingsport Hematology-Oncology
🇺🇸Kingsport, Tennessee, United States
Center for Oncology Research and Treatment, PA
🇺🇸Dallas, Texas, United States
The West Clinic
🇺🇸Memphis, Tennessee, United States
Tyler Cancer Center
🇺🇸Tyler, Texas, United States
South Texas Oncology & Hematology
🇺🇸San Antonio, Texas, United States
Coastal Bend Cancer Center
🇺🇸Corpus Christi, Texas, United States
Southwest Regional Cancer Center
🇺🇸Austin, Texas, United States
Lynchburg Oncology
🇺🇸Lynchburg, Virginia, United States
St. Joseph Regional Cancer Ctr.
🇺🇸Bryan, Texas, United States
Cancer Outreach
🇺🇸Abingdon, Virginia, United States
Oncology/Hematology Association of SW VA
🇺🇸Roanoke, Virginia, United States
Virginia Cancer Institute
🇺🇸Richmond, Virginia, United States
Western WA Med. Grp. Oncology
🇺🇸Everett, Washington, United States
Western Washington Oncology
🇺🇸Lacey, Washington, United States
Oncology Alliance, S.C.
🇺🇸Glendale, Wisconsin, United States
Space Coast Medical
🇺🇸Titusville, Florida, United States