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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00086268
Other study ID # CZOL446EUS75
Secondary ID US 75
Status Completed
Phase Phase 3
First received June 29, 2004
Last updated September 12, 2017
Start date April 2004
Est. completion date October 2007

Study information

Verified date September 2017
Source Novartis
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study will evaluate the effects of an investigational drug in combination with chemotherapy in patients with stage IIIB/IV non-small cell lung cancer. This study will measure the effects of this combination on progression of lung cancer, cancer response to treatments, and development of cancer-related bone lesions.


Other known NCT identifiers
  • NCT00093717

Recruitment information / eligibility

Status Completed
Enrollment 250
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Male or Female patients at least of 18 years old

- Patients with diagnosed non-small cell lung cancer that cannot be treated by surgery

- Women must not be pregnant or attempting to become pregnant

- Able and willing to sign informed consent

Exclusion Criteria:

- Patients with cancer that has spread to the bone

- Patients with cancer that has spread to the brain who are receiving treatment

- Patients with kidney disease

- Patients treated with other investigational drugs

Study Design


Intervention

Drug:
zoledronic acid

Taxotere

Carboplatin


Locations

Country Name City State
United States New Mexico Oncology Hematology Consultants, Ltd. Albuquerque New Mexico
United States Emory University Atlanta Georgia
United States Peachtree Hematology & Oncology Atlanta Georgia
United States Barberton Citizens Hospital-Cancer Center Barberton Ohio
United States Hematology/Oncology Clinic Baton Rouge Louisiana
United States Mary Bird Perkins Cancer Center Baton Rouge Louisiana
United States Engracio Cortes, MD Bayside New York
United States Odyssey Research Belle Haven Virginia
United States Oncology Care Associates Bethesda Maryland
United States Lynn Regional Cancer Center Boca Raton Florida
United States Charleston Cancer Center Charleston South Carolina
United States Charleston Hematology Oncology Charleston South Carolina
United States Presbyterian Hospital Charlotte North Carolina
United States St. Louis Cancer Care Chesterfield Missouri
United States Advocate Illinois Masonic Medical Center Creticos Cancer Center Chicago Illinois
United States Cancer Center of Colorado Springs Colorado Springs Colorado
United States Liberty Hematology-Oncology Columbia South Carolina
United States Cancer Specialists of South Texas Corpus Christi Texas
United States Dayton Clinical Oncology Program Dayton Ohio
United States Karmanos Cancer Institute Detroit Michigan
United States East Orange VA Medical System East Orange New Jersey
United States NorthBay Cancer Center Fairfield California
United States San Juan Regional Cancer Ctr. Farmington New Mexico
United States The Jones Clinic Germantown Tennessee
United States Arena Oncology Assoc. Great Neck New York
United States Southern Oncology Research Grifton North Carolina
United States Kaiser Foundation Hospital Honolulu Hawaii
United States Straub Clinic & Hospital Honolulu Hawaii
United States Clinical Research Consultants Hoover Alabama
United States Howell Office Plaza Howell New Jersey
United States New Hope Cancer Centers Hudson Florida
United States Central Indiana Cancer Centers Indianapolis Indiana
United States NEA Clinic Jonesboro Arkansas
United States Kalamazoo Hematology & Oncology Kalamazoo Michigan
United States Oceola Cancer Center Kissimmee Florida
United States Knoxville Cancer Center Knoxville Tennessee
United States Oncology Institute of Greater Lafayette Lafayette Indiana
United States Nevada Cancer Center Las Vegas Nevada
United States Southern Nevada Cancer Research Foundation Las Vegas Nevada
United States Kansas City Cancer Ctr. South Lenexa Kansas
United States Southeast Nebraska Cancer Center Lincoln Nebraska
United States UCLA Los Angeles California
United States Atlantic Hem Onc Associates, LLC Manasquan New Jersey
United States Hematology Oncology Associates Medford Oregon
United States VA Medical Center Miami Florida
United States Innovative Medical Research of South Florida, Inc. Miami Shores Florida
United States Clinical Trials and Research Associates, Inc. Montebello California
United States West Virginia University Morgantown West Virginia
United States Hematology/Oncology Assoc. of South Jersey Mount Holly New Jersey
United States Community Hospital, Cancer Research Dept. Munster Indiana
United States NCH Healthcare System Oncology Research Naples Florida
United States Cancer Specialists of Oklahoma Oklahoma City Oklahoma
United States Med. Oncology Care Associates Orange California
United States Metcare Oncology Ormond Beach Florida
United States Hematology-Oncology Associates Pensacola Florida
United States Berkshire Hematology Oncology PC Pittsfield Massachusetts
United States James P. Wilmot Cancer Center Rochester New York
United States OSF Center for Cancer Care Rockford Illinois
United States Park Nicollett Institute Saint Louis Park Minnesota
United States Cancer Center of Santa Barbara Santa Barbara California
United States New Mexico Cancer Care Associates Santa Fe New Mexico
United States Maine Center for Cancer Medicine Scarborough Maine
United States Odyssey Research Scottsbluff Nebraska
United States AMIT SHAH Medical Group Sebring Florida
United States LSU Health Sciences Center Shreveport Louisiana
United States Northern Indiana Oncology Associates South Bend Indiana
United States Highlands Oncology Group Springdale Arkansas
United States Springfield Clinic, LLP Springfield Illinois
United States Santee Hematology/Oncology Sumter South Carolina
United States SUNY Upstate Medical University Syracuse New York
United States Syracuse VA Medical Center Syracuse New York
United States Northern Hematology-Oncology Thornton Colorado
United States Mitchell Folbe, MD, PC Troy Michigan
United States Arizona Oncology Assoc. Tucson Arizona
United States Blood and Cancer Center of East Texas Tyler Texas
United States Tyler Hematology Oncology, PA Tyler Texas
United States Cancer Institute of New Jersey at Cooper University Hospital Voorhees New Jersey
United States Cedar Valley Medical Specialists Waterloo Iowa
United States Masoom Kandahari, MD Woodbridge Virginia
United States Forum Health Cancer CareCenter Youngstown Ohio

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

References & Publications (1)

Pandya KJ, Gajra A, Warsi GM, Argonza-Aviles E, Ericson SG, Wozniak AJ. Multicenter, randomized, phase 2 study of zoledronic acid in combination with docetaxel and carboplatin in patients with unresectable stage IIIB or stage IV non-small cell lung cancer — View Citation

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