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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00099541
Other study ID # CZOL446EUS99
Secondary ID US99Z-NEXT
Status Completed
Phase Phase 4
First received December 15, 2004
Last updated November 20, 2009
Start date November 2004
Est. completion date November 2007

Study information

Verified date November 2009
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date November 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

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


Intervention

Drug:
zoledronic acid


Locations

Country Name City State
United States Cancer Outreach Abingdon Virginia
United States Summa Health System Akron Ohio
United States Cabrini Center for Cancer Care Alexandria Louisiana
United States Pacific Cancer Medical Center Inc. Anaheim California
United States Hematology & Oncology of N.E. GA Athens Georgia
United States Augusta Onc. Associates Augusta Georgia
United States Southwest Regional Cancer Center Austin Texas
United States Maryland Hematology/Oncology Associates Baltimore Maryland
United States Sinai Hospital Baltimore Maryland
United States Oncology-Hematology of Lehigh Valley PC Bethlehem Pennsylvania
United States Birmingham Hematology and Oncology Associates Birmingham Alabama
United States St. Joseph Regional Cancer Ctr. Bryan Texas
United States Alamance Regional Medical Ctr. Cancer Ctr. Burlington North Carolina
United States Sierra Nevada Oncology Care Carson City Nevada
United States Associates in Oncology and Hematology Chattanooga Tennessee
United States Center For Cancer & Hematologic Disease Cherry Hill New Jersey
United States David H. Smith, MD Chestertown Maryland
United States OHCI Cincinnati Ohio
United States Oncology-Hematology Associates, PA Clinton Maryland
United States The Family Cancer Center, PLLC Collierville Tennessee
United States Maryland Oncology Columbia Maryland
United States South Carolina Oncology Assoc., PA Columbia South Carolina
United States Bay Area Cancer Research Group Concord California
United States Coastal Bend Cancer Center Corpus Christi Texas
United States Center for Oncology Research and Treatment, PA Dallas Texas
United States Regional Cancer Center Danville Illinois
United States Rocky Mountain Cancer Centers Denver Colorado
United States Henry Ford Medical Center Detroit Michigan
United States Hematology-Oncology Associates of CNY East Syracuse New York
United States The Cancer Institute at Alexian Brothers Elk Grove Village Illinois
United States Western WA Med. Grp. Oncology Everett Washington
United States Singh & Arora Hematology/Oncology Flint Michigan
United States Lekha Babu M.D Ltd. Flossmoor Illinois
United States Front Range Cancer Specialists Fort Collins Colorado
United States Hembree Cancer Center-St. Edward Mercy Medical Center Fort Smith Arkansas
United States Fresno Hem/Onc Medical Group Fresno California
United States Gainesville Hematology Oncology Associates Gainesville Florida
United States Oncology Alliance, S.C. Glendale Wisconsin
United States Greeley Medical Clinic Greeley Colorado
United States Beaver Med Group Highland California
United States Oncology Consultants P.A. Houston Texas
United States Huntington Medical Group Huntington Station New York
United States Baptist Cancer Institute Jacksonville Florida
United States Broome Oncology Johnson City New York
United States McLeod Cancer & Blood Center Johnson City Tennessee
United States Paul V. Woolley MD PC Johnstown Pennsylvania
United States Joliet Oncology Hematology Associates, Ltd Joliet Illinois
United States Heartland Hematology/Oncology Associates Inc. Kansas City Missouri
United States Kingsport Hematology-Oncology Kingsport Tennessee
United States Western Washington Oncology Lacey Washington
United States Louisiana Oncology Associates Lafayette Louisiana
United States LaGrange Oncology Associates LaGrange Illinois
United States Center for Cancer Care & Research Lakeland Florida
United States Western Hematology/Oncology Lakewood Colorado
United States Nevada Cancer Center Las Vegas Nevada
United States US Oncology Las Vegas Nevada
United States Lake Heart & Cancer Center Leesburg Florida
United States Kentuckiana Cancer Center, PLLC Louisville Kentucky
United States Lynchburg Oncology Lynchburg Virginia
United States Mukesh Bhatt, MD Medina Ohio
United States Melbourne Internal Medicine Assoc (MIMA) Century Research Melbourne Florida
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 Hematology and Oncology Specialists Metairie Louisiana
United States Caritas Holy Family Hospital Methuen Massachusetts
United States HOANNJ/Carol G. Simon Cancer Center Morristown New Jersey
United States Medical Consultants, PC Muncie Indiana
United States Pasco Pinellas Cancer Center New Port Richey Florida
United States Kin Yui Lam, MD New York New York
United States Christiana Care Health Services Newark Delaware
United States Northwest Medical Specialists Niles Illinois
United States Ocala Oncology Center Ocala Florida
United States M. Farouk Kanaa, MD, Inc. Oklahoma City Oklahoma
United States Mid- Florida Hematology & Oncology Centers, PA Orange City Florida
United States W. Kentucky Hematology's Oncology Group, PSC Paducah Kentucky
United States Raleigh Hematology Oncology Associates Raleigh North Carolina
United States Virginia Cancer Institute Richmond Virginia
United States Oncology/Hematology Association of SW VA Roanoke Virginia
United States Hubert Humphrey Cancer Center Robbinsdale Minnesota
United States South Texas Oncology & Hematology San Antonio Texas
United States Redwood Regional Medical Group Santa Rosa California
United States Swedish Health Services Seattle Washington
United States Highland Clinic, APMC Shreveport Louisiana
United States Midwest Cancer Research Group Skokie Illinois
United States Suburban Hematology-Oncology Snellville Georgia
United States Medical Hematology/Oncology Somerset New Jersey
United States Palmetto Hematology Oncology, P.C Spartanburg South Carolina
United States St. Joseph Onocology, Inc. St. Joseph Missouri
United States St. John's Mercy Medical Center St. Louis Missouri
United States University Hematology Oncology, Inc. St. Louis Missouri
United States Hematology Oncology PC Stamford Connecticut
United States Stockton Hem. Onc. Stockton California
United States Space Coast Medical Titusville Florida
United States St. Joseph Medical Center Towson Maryland
United States Cancer Treatment Center Tulsa Oklahoma
United States Tyler Cancer Center Tyler Texas
United States Vero Beach Hematology/Oncology Vero Beach Florida
United States Chester County Hematology/Oncology Services West Chester Pennsylvania
United States Lawrence M. Stallings, MD, LLC Wooster Ohio
United States Fallon Clinic Worcester Massachusetts

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Group 1: Time to the first occurrence of an skeletal related event (SRE) in unresectable stage IIIB/IV NSCLC patients with bone metastases
Primary Group 2: Observational
Secondary Patients with an SRE will be evaluated for:
Secondary Time from stage IIIB/IV NSCLC diagnosis to progression to bone
Secondary Time from bone metastasis diagnosis to presentation of clinical symptoms of skeletal complications
Secondary The effect of serum NTX levels on the development of skeletal events (SREs), and
Secondary Overall survival
Secondary Group 2: Obervational
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