Non-small Cell Lung Cancer Study US75 (Z-PACT) (ZPACT)

September 12, 2017 updated by: Novartis Pharmaceuticals
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

250

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Hoover, Alabama, United States, 35216
        • Clinical Research Consultants
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Arizona Oncology Assoc.
    • Arkansas
      • Jonesboro, Arkansas, United States, 72401
        • NEA Clinic
      • Springdale, Arkansas, United States, 72764
        • Highlands Oncology Group
    • California
      • Fairfield, California, United States, 94533
        • Northbay Cancer Center
      • Los Angeles, California, United States, 91401
        • UCLA
      • Montebello, California, United States, 90640
        • Clinical Trials and Research Associates, Inc.
      • Orange, California, United States, 92868
        • Med. Oncology Care Associates
      • Santa Barbara, California, United States, 93105
        • Cancer Center of Santa Barbara
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Cancer Center of Colorado Springs
      • Thornton, Colorado, United States, 80260
        • Northern Hematology-Oncology
    • Florida
      • Boca Raton, Florida, United States, 33428
        • Lynn Regional Cancer Center
      • Hudson, Florida, United States, 34667
        • New Hope Cancer Centers
      • Kissimmee, Florida, United States, 34741
        • Oceola Cancer Center
      • Miami, Florida, United States, 33125
        • VA Medical Center
      • Miami Shores, Florida, United States, 33138
        • Innovative Medical Research of South Florida, Inc.
      • Naples, Florida, United States, 34102
        • NCH Healthcare System Oncology Research
      • Ormond Beach, Florida, United States, 32174
        • Metcare Oncology
      • Pensacola, Florida, United States, 32501
        • Hematology-Oncology Associates
      • Sebring, Florida, United States, 33872
        • AMIT SHAH Medical Group
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
      • Atlanta, Georgia, United States, 30309
        • Peachtree Hematology & Oncology
    • Hawaii
      • Honolulu, Hawaii, United States, 96819
        • Kaiser Foundation Hospital
      • Honolulu, Hawaii, United States, 96813
        • Straub Clinic & Hospital
    • Illinois
      • Chicago, Illinois, United States, 60657
        • Advocate Illinois Masonic Medical Center Creticos Cancer Center
      • Rockford, Illinois, United States, 61108
        • OSF Center for Cancer Care
      • Springfield, Illinois, United States, 62703
        • Springfield Clinic, Llp
    • Indiana
      • Indianapolis, Indiana, United States, 46219
        • Central Indiana Cancer Centers
      • Lafayette, Indiana, United States, 47904
        • Oncology Institute of Greater Lafayette
      • Munster, Indiana, United States, 46321
        • Community Hospital, Cancer Research Dept.
      • South Bend, Indiana, United States, 46617
        • Northern Indiana Oncology Associates
    • Iowa
      • Waterloo, Iowa, United States, 50702
        • Cedar Valley Medical Specialists
    • Kansas
      • Lenexa, Kansas, United States, 66214
        • Kansas City Cancer Ctr. South
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Mary Bird Perkins Cancer Center
      • Baton Rouge, Louisiana, United States, 70808
        • Hematology/Oncology Clinic
      • Shreveport, Louisiana, United States, 71103
        • LSU Health Sciences Center
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Center For Cancer Medicine
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Oncology Care Associates
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Berkshire Hematology Oncology PC
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Karmanos Cancer Institute
      • Kalamazoo, Michigan, United States, 49048
        • Kalamazoo Hematology & Oncology
      • Troy, Michigan, United States, 48085
        • Mitchell Folbe, Md, Pc
    • Minnesota
      • Saint Louis Park, Minnesota, United States, 55416
        • Park Nicollett Institute
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • St. Louis Cancer Care
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Cancer Center
      • Scottsbluff, Nebraska, United States, 69361
        • Odyssey Research
    • Nevada
      • Las Vegas, Nevada, United States, 89109
        • Nevada Cancer Center
      • Las Vegas, Nevada, United States, 89106
        • Southern Nevada Cancer Research Foundation
    • New Jersey
      • East Orange, New Jersey, United States, 07018
        • East Orange VA Medical System
      • Howell, New Jersey, United States, 07731
        • Howell Office Plaza
      • Manasquan, New Jersey, United States, 08736
        • Atlantic Hem Onc Associates, LLC
      • Mount Holly, New Jersey, United States, 08060
        • Hematology/Oncology Assoc. of South Jersey
      • Voorhees, New Jersey, United States, 08043
        • Cancer Institute of New Jersey at Cooper University Hospital
    • New Mexico
      • Albuquerque, New Mexico, United States, 87109
        • New Mexico Oncology Hematology Consultants, Ltd.
      • Farmington, New Mexico, United States, 87401
        • San Juan Regional Cancer Ctr.
      • Santa Fe, New Mexico, United States, 87505
        • New Mexico Cancer Care Associates
    • New York
      • Bayside, New York, United States, 11361
        • Engracio Cortes, MD
      • Great Neck, New York, United States, 11021
        • Arena Oncology Assoc.
      • Rochester, New York, United States, 16642
        • James P. Wilmot Cancer Center
      • Syracuse, New York, United States, 13210
        • SUNY Upstate Medical University
      • Syracuse, New York, United States, 13210
        • Syracuse VA Medical Center
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Presbyterian Hospital
      • Grifton, North Carolina, United States, 28530
        • Southern Oncology Research
    • Ohio
      • Barberton, Ohio, United States, 44203
        • Barberton Citizens Hospital-Cancer Center
      • Dayton, Ohio, United States, 45429
        • Dayton Clinical Oncology Program
      • Youngstown, Ohio, United States, 44501
        • Forum Health Cancer CareCenter
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Cancer Specialists Of Oklahoma
    • Oregon
      • Medford, Oregon, United States, 97504
        • Hematology Oncology Associates
    • South Carolina
      • Charleston, South Carolina, United States, 29403
        • Charleston Hematology Oncology
      • Charleston, South Carolina, United States, 29406
        • Charleston Cancer Center
      • Columbia, South Carolina, United States, 29203
        • Liberty Hematology-Oncology
      • Sumter, South Carolina, United States, 29150
        • Santee Hematology/Oncology
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • The Jones Clinic
      • Knoxville, Tennessee, United States, 27909
        • Knoxville Cancer Center
    • Texas
      • Corpus Christi, Texas, United States, 78412
        • Cancer Specialists of South Texas
      • Tyler, Texas, United States, 75701
        • Blood and Cancer Center of East Texas
      • Tyler, Texas, United States, 75701
        • Tyler Hematology Oncology, PA
    • Virginia
      • Belle Haven, Virginia, United States, 23306
        • Odyssey Research
      • Woodbridge, Virginia, United States, 22191
        • Masoom Kandahari, MD
    • West Virginia
      • Morgantown, West Virginia, United States, 26506
        • West Virginia University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zometa®
4mg monthly for 12 months from date of first chemotherapy dose
Drug: zoledronic acid
Drug: Carboplatin
Drug: Taxotere
No Intervention: no further treatment
Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2004

Primary Completion (Actual)

October 1, 2007

Study Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

June 29, 2004

First Submitted That Met QC Criteria

June 30, 2004

First Posted (Estimate)

July 1, 2004

Study Record Updates

Last Update Posted (Actual)

September 13, 2017

Last Update Submitted That Met QC Criteria

September 12, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CZOL446EUS75
  • US 75

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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