Clinical trial NCT00086268: Non-small Cell Lung Cancer Study US75 (Z-PACT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non Small Cell Lung Carcinoma
Keywords: lung cancer
ZPACT
US75
Bone Metastases
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2004-07-01
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hoover
country: United States
facility: Clinical Research Consultants
state: Alabama
city: Tucson
country: United States
facility: Arizona Oncology Assoc.
state: Arizona
city: Jonesboro
country: United States
facility: NEA Clinic
state: Arkansas
city: Springdale
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Fairfield
country: United States
facility: NorthBay Cancer Center
state: California
city: Los Angeles
country: United States
facility: UCLA
state: California
city: Montebello
country: United States
facility: Clinical Trials and Research Associates, Inc.
state: California
city: Orange
country: United States
facility: Med. Oncology Care Associates
state: California
city: Santa Barbara
country: United States
facility: Cancer Center of Santa Barbara
state: California
city: Colorado Springs
country: United States
facility: Cancer Center of Colorado Springs
state: Colorado
city: Thornton
country: United States
facility: Northern Hematology-Oncology
state: Colorado
city: Boca Raton
country: United States
facility: Lynn Regional Cancer Center
state: Florida
city: Hudson
country: United States
facility: New Hope Cancer Centers
state: Florida
city: Kissimmee
country: United States
facility: Oceola Cancer Center
state: Florida
city: Miami Shores
country: United States
facility: Innovative Medical Research of South Florida, Inc.
state: Florida
city: Miami
country: United States
facility: VA Medical Center
state: Florida
city: Naples
country: United States
facility: NCH Healthcare System Oncology Research
state: Florida
city: Ormond Beach
country: United States
facility: Metcare Oncology
state: Florida
city: Pensacola
country: United States
facility: Hematology-Oncology Associates
state: Florida
city: Sebring
country: United States
facility: AMIT SHAH Medical Group
state: Florida
city: Atlanta
country: United States
facility: Peachtree Hematology & Oncology
state: Georgia
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Honolulu
country: United States
facility: Straub Clinic & Hospital
state: Hawaii
city: Honolulu
country: United States
facility: Kaiser Foundation Hospital
state: Hawaii
city: Chicago
country: United States
facility: Advocate Illinois Masonic Medical Center Creticos Cancer Center
state: Illinois
city: Rockford
country: United States
facility: OSF Center for Cancer Care
state: Illinois
city: Springfield
country: United States
facility: Springfield Clinic, LLP
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Lafayette
country: United States
facility: Oncology Institute of Greater Lafayette
state: Indiana
city: Munster
country: United States
facility: Community Hospital, Cancer Research Dept.
state: Indiana
city: South Bend
country: United States
facility: Northern Indiana Oncology Associates
state: Indiana
city: Waterloo
country: United States
facility: Cedar Valley Medical Specialists
state: Iowa
city: Lenexa
country: United States
facility: Kansas City Cancer Ctr. South
state: Kansas
city: Baton Rouge
country: United States
facility: Hematology/Oncology Clinic
state: Louisiana
city: Baton Rouge
country: United States
facility: Mary Bird Perkins Cancer Center
state: Louisiana
city: Shreveport
country: United States
facility: LSU Health Sciences Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Center for Cancer Medicine
state: Maine
city: Bethesda
country: United States
facility: Oncology Care Associates
state: Maryland
city: Pittsfield
country: United States
facility: Berkshire Hematology Oncology PC
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute
state: Michigan
city: Kalamazoo
country: United States
facility: Kalamazoo Hematology & Oncology
state: Michigan
city: Troy
country: United States
facility: Mitchell Folbe, MD, PC
state: Michigan
city: Saint Louis Park
country: United States
facility: Park Nicollett Institute
state: Minnesota
city: Chesterfield
country: United States
facility: St. Louis Cancer Care
state: Missouri
city: Lincoln
country: United States
facility: Southeast Nebraska Cancer Center
state: Nebraska
city: Scottsbluff
country: United States
facility: Odyssey Research
state: Nebraska
city: Las Vegas
country: United States
facility: Southern Nevada Cancer Research Foundation
state: Nevada
city: Las Vegas
country: United States
facility: Nevada Cancer Center
state: Nevada
city: East Orange
country: United States
facility: East Orange VA Medical System
state: New Jersey
city: Howell
country: United States
facility: Howell Office Plaza
state: New Jersey
city: Manasquan
country: United States
facility: Atlantic Hem Onc Associates, LLC
state: New Jersey
city: Mount Holly
country: United States
facility: Hematology/Oncology Assoc. of South Jersey
state: New Jersey
city: Voorhees
country: United States
facility: Cancer Institute of New Jersey at Cooper University Hospital
state: New Jersey
city: Albuquerque
country: United States
facility: New Mexico Oncology Hematology Consultants, Ltd.
state: New Mexico
city: Farmington
country: United States
facility: San Juan Regional Cancer Ctr.
state: New Mexico
city: Santa Fe
country: United States
facility: New Mexico Cancer Care Associates
state: New Mexico
city: Bayside
country: United States
facility: Engracio Cortes, MD
state: New York
city: Great Neck
country: United States
facility: Arena Oncology Assoc.
state: New York
city: Rochester
country: United States
facility: James P. Wilmot Cancer Center
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University
state: New York
city: Syracuse
country: United States
facility: Syracuse VA Medical Center
state: New York
city: Charlotte
country: United States
facility: Presbyterian Hospital
state: North Carolina
city: Grifton
country: United States
facility: Southern Oncology Research
state: North Carolina
city: Barberton
country: United States
facility: Barberton Citizens Hospital-Cancer Center
state: Ohio
city: Dayton
country: United States
facility: Dayton Clinical Oncology Program
state: Ohio
city: Youngstown
country: United States
facility: Forum Health Cancer CareCenter
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Specialists of Oklahoma
state: Oklahoma
city: Medford
country: United States
facility: Hematology Oncology Associates
state: Oregon
city: Charleston
country: United States
facility: Charleston Hematology Oncology
state: South Carolina
city: Charleston
country: United States
facility: Charleston Cancer Center
state: South Carolina
city: Columbia
country: United States
facility: Liberty Hematology-Oncology
state: South Carolina
city: Sumter
country: United States
facility: Santee Hematology/Oncology
state: South Carolina
city: Germantown
country: United States
facility: The Jones Clinic
state: Tennessee
city: Knoxville
country: United States
facility: Knoxville Cancer Center
state: Tennessee
city: Corpus Christi
country: United States
facility: Cancer Specialists of South Texas
state: Texas
city: Tyler
country: United States
facility: Blood and Cancer Center of East Texas
state: Texas
city: Tyler
country: United States
facility: Tyler Hematology Oncology, PA
state: Texas
city: Belle Haven
country: United States
facility: Odyssey Research
state: Virginia
city: Woodbridge
country: United States
facility: Masoom Kandahari, MD
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: 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. Lung Cancer. 2010 Mar;67(3):330-8. doi: 10.1016/j.lungcan.2009.04.020. Epub 2009 Jun 2.