Non-small Cell Lung Cancer Study US75 (Z-PACT)
ZPACT
2 other identifiers
interventional
250
1 country
80
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2004
Typical duration for phase_3
80 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2004
CompletedFirst Submitted
Initial submission to the registry
June 29, 2004
CompletedFirst Posted
Study publicly available on registry
July 1, 2004
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2007
CompletedSeptember 13, 2017
September 1, 2017
3.5 years
June 29, 2004
September 12, 2017
Conditions
Keywords
Study Arms (2)
Zometa®
EXPERIMENTAL4mg monthly for 12 months from date of first chemotherapy dose
no further treatment
NO INTERVENTIONControl arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (80)
Clinical Research Consultants
Hoover, Alabama, 35216, United States
Arizona Oncology Assoc.
Tucson, Arizona, 85715, United States
NEA Clinic
Jonesboro, Arkansas, 72401, United States
Highlands Oncology Group
Springdale, Arkansas, 72764, United States
NorthBay Cancer Center
Fairfield, California, 94533, United States
UCLA
Los Angeles, California, 91401, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Med. Oncology Care Associates
Orange, California, 92868, United States
Cancer Center of Santa Barbara
Santa Barbara, California, 93105, United States
Cancer Center of Colorado Springs
Colorado Springs, Colorado, 80907, United States
Northern Hematology-Oncology
Thornton, Colorado, 80260, United States
Lynn Regional Cancer Center
Boca Raton, Florida, 33428, United States
New Hope Cancer Centers
Hudson, Florida, 34667, United States
Oceola Cancer Center
Kissimmee, Florida, 34741, United States
VA Medical Center
Miami, Florida, 33125, United States
Innovative Medical Research of South Florida, Inc.
Miami Shores, Florida, 33138, United States
NCH Healthcare System Oncology Research
Naples, Florida, 34102, United States
Metcare Oncology
Ormond Beach, Florida, 32174, United States
Hematology-Oncology Associates
Pensacola, Florida, 32501, United States
AMIT SHAH Medical Group
Sebring, Florida, 33872, United States
Peachtree Hematology & Oncology
Atlanta, Georgia, 30309, United States
Emory University
Atlanta, Georgia, 30322, United States
Straub Clinic & Hospital
Honolulu, Hawaii, 96813, United States
Kaiser Foundation Hospital
Honolulu, Hawaii, 96819, United States
Advocate Illinois Masonic Medical Center Creticos Cancer Center
Chicago, Illinois, 60657, United States
OSF Center for Cancer Care
Rockford, Illinois, 61108, United States
Springfield Clinic, LLP
Springfield, Illinois, 62703, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46219, United States
Oncology Institute of Greater Lafayette
Lafayette, Indiana, 47904, United States
Community Hospital, Cancer Research Dept.
Munster, Indiana, 46321, United States
Northern Indiana Oncology Associates
South Bend, Indiana, 46617, United States
Cedar Valley Medical Specialists
Waterloo, Iowa, 50702, United States
Kansas City Cancer Ctr. South
Lenexa, Kansas, 66214, United States
Hematology/Oncology Clinic
Baton Rouge, Louisiana, 70808, United States
Mary Bird Perkins Cancer Center
Baton Rouge, Louisiana, 70809, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Maine Center for Cancer Medicine
Scarborough, Maine, 04074, United States
Oncology Care Associates
Bethesda, Maryland, 20817, United States
Berkshire Hematology Oncology PC
Pittsfield, Massachusetts, 01201, United States
Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Kalamazoo Hematology & Oncology
Kalamazoo, Michigan, 49048, United States
Mitchell Folbe, MD, PC
Troy, Michigan, 48085, United States
Park Nicollett Institute
Saint Louis Park, Minnesota, 55416, United States
St. Louis Cancer Care
Chesterfield, Missouri, 63017, United States
Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Odyssey Research
Scottsbluff, Nebraska, 69361, United States
Southern Nevada Cancer Research Foundation
Las Vegas, Nevada, 89106, United States
Nevada Cancer Center
Las Vegas, Nevada, 89109, United States
East Orange VA Medical System
East Orange, New Jersey, 07018, United States
Howell Office Plaza
Howell Township, New Jersey, 07731, United States
Atlantic Hem Onc Associates, LLC
Manasquan, New Jersey, 08736, United States
Hematology/Oncology Assoc. of South Jersey
Mount Holly, New Jersey, 08060, United States
Cancer Institute of New Jersey at Cooper University Hospital
Voorhees Township, New Jersey, 08043, United States
New Mexico Oncology Hematology Consultants, Ltd.
Albuquerque, New Mexico, 87109, United States
San Juan Regional Cancer Ctr.
Farmington, New Mexico, 87401, United States
New Mexico Cancer Care Associates
Santa Fe, New Mexico, 87505, United States
Engracio Cortes, MD
Bayside, New York, 11361, United States
Arena Oncology Assoc.
Great Neck, New York, 11021, United States
James P. Wilmot Cancer Center
Rochester, New York, 16642, United States
SUNY Upstate Medical University
Syracuse, New York, 13210, United States
Syracuse VA Medical Center
Syracuse, New York, 13210, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Southern Oncology Research
Grifton, North Carolina, 28530, United States
Barberton Citizens Hospital-Cancer Center
Barberton, Ohio, 44203, United States
Dayton Clinical Oncology Program
Dayton, Ohio, 45429, United States
Forum Health Cancer CareCenter
Youngstown, Ohio, 44501, United States
Cancer Specialists of Oklahoma
Oklahoma City, Oklahoma, 73112, United States
Hematology Oncology Associates
Medford, Oregon, 97504, United States
Charleston Hematology Oncology
Charleston, South Carolina, 29403, United States
Charleston Cancer Center
Charleston, South Carolina, 29406, United States
Liberty Hematology-Oncology
Columbia, South Carolina, 29203, United States
Santee Hematology/Oncology
Sumter, South Carolina, 29150, United States
The Jones Clinic
Germantown, Tennessee, 38138, United States
Knoxville Cancer Center
Knoxville, Tennessee, 27909, United States
Cancer Specialists of South Texas
Corpus Christi, Texas, 78412, United States
Blood and Cancer Center of East Texas
Tyler, Texas, 75701, United States
Tyler Hematology Oncology, PA
Tyler, Texas, 75701, United States
Odyssey Research
Belle Haven, Virginia, 23306, United States
Masoom Kandahari, MD
Woodbridge, Virginia, 22191, United States
West Virginia University
Morgantown, West Virginia, 26506, United States
Related 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. Lung Cancer. 2010 Mar;67(3):330-8. doi: 10.1016/j.lungcan.2009.04.020. Epub 2009 Jun 2.
PMID: 19493585RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 29, 2004
First Posted
July 1, 2004
Study Start
April 1, 2004
Primary Completion
October 1, 2007
Study Completion
October 1, 2007
Last Updated
September 13, 2017
Record last verified: 2017-09