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Non Small Cell Lung CarcinomaPhase 3ZPACTNCT00086268

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

A Phase 3 study testing zoledronic acid, Taxotere and Carboplatin in people with Non Small Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 80 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Non Small Cell Lung Carcinoma
What is being tested?
zoledronic acid, Taxotere and Carboplatin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
80 sitesUnited States
Study dates
Apr 2004to Oct 2007
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

80 sites in 1 country.

80 sites in 1 country

United States80 sites

  • New Mexico Oncology Hematology Consultants, Ltd.

    Albuquerque, New Mexico, 87109

  • Peachtree Hematology & Oncology

    Atlanta, Georgia, 30309

  • Emory University

    Atlanta, Georgia, 30322

  • Barberton Citizens Hospital-Cancer Center

    Barberton, Ohio, 44203

  • Hematology/Oncology Clinic

    Baton Rouge, Louisiana, 70808

  • Mary Bird Perkins Cancer Center

    Baton Rouge, Louisiana, 70809

  • Engracio Cortes, MD

    Bayside, New York, 11361

  • Odyssey Research

    Belle Haven, Virginia, 23306

  • Oncology Care Associates

    Bethesda, Maryland, 20817

  • Lynn Regional Cancer Center

    Boca Raton, Florida, 33428

  • Charleston Hematology Oncology

    Charleston, South Carolina, 29403

  • Charleston Cancer Center

    Charleston, South Carolina, 29406

  • Presbyterian Hospital

    Charlotte, North Carolina, 28204

  • St. Louis Cancer Care

    Chesterfield, Missouri, 63017

  • Advocate Illinois Masonic Medical Center Creticos Cancer Center

    Chicago, Illinois, 60657

  • Cancer Center of Colorado Springs

    Colorado Springs, Colorado, 80907

  • Liberty Hematology-Oncology

    Columbia, South Carolina, 29203

  • Cancer Specialists of South Texas

    Corpus Christi, Texas, 78412

  • Dayton Clinical Oncology Program

    Dayton, Ohio, 45429

  • Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • East Orange VA Medical System

    East Orange, New Jersey, 07018

  • NorthBay Cancer Center

    Fairfield, California, 94533

  • San Juan Regional Cancer Ctr.

    Farmington, New Mexico, 87401

  • The Jones Clinic

    Germantown, Tennessee, 38138

  • Arena Oncology Assoc.

    Great Neck, New York, 11021

  • Southern Oncology Research

    Grifton, North Carolina, 28530

  • Straub Clinic & Hospital

    Honolulu, Hawaii, 96813

  • Kaiser Foundation Hospital

    Honolulu, Hawaii, 96819

  • Clinical Research Consultants

    Hoover, Alabama, 35216

  • Howell Office Plaza

    Howell Township, New Jersey, 07731

  • New Hope Cancer Centers

    Hudson, Florida, 34667

  • Central Indiana Cancer Centers

    Indianapolis, Indiana, 46219

  • NEA Clinic

    Jonesboro, Arkansas, 72401

  • Kalamazoo Hematology & Oncology

    Kalamazoo, Michigan, 49048

  • Oceola Cancer Center

    Kissimmee, Florida, 34741

  • Knoxville Cancer Center

    Knoxville, Tennessee, 27909

  • Oncology Institute of Greater Lafayette

    Lafayette, Indiana, 47904

  • Southern Nevada Cancer Research Foundation

    Las Vegas, Nevada, 89106

  • Nevada Cancer Center

    Las Vegas, Nevada, 89109

  • Kansas City Cancer Ctr. South

    Lenexa, Kansas, 66214

  • Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • UCLA

    Los Angeles, California, 91401

  • Atlantic Hem Onc Associates, LLC

    Manasquan, New Jersey, 08736

  • Hematology Oncology Associates

    Medford, Oregon, 97504

  • VA Medical Center

    Miami, Florida, 33125

  • Innovative Medical Research of South Florida, Inc.

    Miami Shores, Florida, 33138

  • Clinical Trials and Research Associates, Inc.

    Montebello, California, 90640

  • West Virginia University

    Morgantown, West Virginia, 26506

  • Hematology/Oncology Assoc. of South Jersey

    Mount Holly, New Jersey, 08060

  • Community Hospital, Cancer Research Dept.

    Munster, Indiana, 46321

  • NCH Healthcare System Oncology Research

    Naples, Florida, 34102

  • Cancer Specialists of Oklahoma

    Oklahoma City, Oklahoma, 73112

  • Med. Oncology Care Associates

    Orange, California, 92868

  • Metcare Oncology

    Ormond Beach, Florida, 32174

  • Hematology-Oncology Associates

    Pensacola, Florida, 32501

  • Berkshire Hematology Oncology PC

    Pittsfield, Massachusetts, 01201

  • James P. Wilmot Cancer Center

    Rochester, New York, 16642

  • OSF Center for Cancer Care

    Rockford, Illinois, 61108

  • Park Nicollett Institute

    Saint Louis Park, Minnesota, 55416

  • Cancer Center of Santa Barbara

    Santa Barbara, California, 93105

  • New Mexico Cancer Care Associates

    Santa Fe, New Mexico, 87505

  • Maine Center for Cancer Medicine

    Scarborough, Maine, 04074

  • Odyssey Research

    Scottsbluff, Nebraska, 69361

  • AMIT SHAH Medical Group

    Sebring, Florida, 33872

  • LSU Health Sciences Center

    Shreveport, Louisiana, 71103

  • Northern Indiana Oncology Associates

    South Bend, Indiana, 46617

  • Highlands Oncology Group

    Springdale, Arkansas, 72764

  • Springfield Clinic, LLP

    Springfield, Illinois, 62703

  • Santee Hematology/Oncology

    Sumter, South Carolina, 29150

  • SUNY Upstate Medical University

    Syracuse, New York, 13210

  • Syracuse VA Medical Center

    Syracuse, New York, 13210

  • Northern Hematology-Oncology

    Thornton, Colorado, 80260

  • Mitchell Folbe, MD, PC

    Troy, Michigan, 48085

  • Arizona Oncology Assoc.

    Tucson, Arizona, 85715

  • Blood and Cancer Center of East Texas

    Tyler, Texas, 75701

  • Tyler Hematology Oncology, PA

    Tyler, Texas, 75701

  • Cancer Institute of New Jersey at Cooper University Hospital

    Voorhees Township, New Jersey, 08043

  • Cedar Valley Medical Specialists

    Waterloo, Iowa, 50702

  • Masoom Kandahari, MD

    Woodbridge, Virginia, 22191

  • Forum Health Cancer CareCenter

    Youngstown, Ohio, 44501

Other trials in United States

About this study

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.

Being tested
zoledronic acid, Taxotere, Carboplatin
Keywords
lung cancer, ZPACT, US75, Bone Metastases
Medical subject headings
Carcinoma, Non-Small-Cell Lung, Lung Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00086268
Study groupRoleWhat they receive
Zometa®Experimental4mg monthly for 12 months from date of first chemotherapy dose
Receives: Drug: zoledronic acid; Drug: Taxotere; Drug: Carboplatin
no further treatmentNo interventionControl arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Jul 2004 (estimated)
  2. Study startApr 2004
  3. Primary completionOct 2007
  4. Study completionOct 2007

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00086268
Sponsor's protocol ID
CZOL446EUS75
Other IDs
US 75
Acronym
ZPACT
Status last verified
Sep 2017
First submitted
29 Jun 2004
Last updated
13 Sep 2017
Results posted
No

Publications

  • 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.

    PubMed 19493585

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing zoledronic acid, Taxotere and Carboplatin in people with Non Small Cell Lung Carcinoma, run by Novartis Pharmaceuticals at 80 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 13 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 80 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00086268, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2017; AzTrials last refreshed its copy on 27 Oct 2026.

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