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

NCT ID: NCT00086268

Last Updated: 2017-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-04-30

Study Completion Date

2007-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Non Small Cell Lung Carcinoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Zometa®

4mg monthly for 12 months from date of first chemotherapy dose

Group Type EXPERIMENTAL

zoledronic acid

Intervention Type DRUG

Taxotere

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

no further treatment

Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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zoledronic acid

Intervention Type DRUG

Taxotere

Intervention Type DRUG

Carboplatin

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Clinical Research Consultants

Hoover, Alabama, United States

Site Status

Arizona Oncology Assoc.

Tucson, Arizona, United States

Site Status

NEA Clinic

Jonesboro, Arkansas, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

NorthBay Cancer Center

Fairfield, California, United States

Site Status

UCLA

Los Angeles, California, United States

Site Status

Clinical Trials and Research Associates, Inc.

Montebello, California, United States

Site Status

Med. Oncology Care Associates

Orange, California, United States

Site Status

Cancer Center of Santa Barbara

Santa Barbara, California, United States

Site Status

Cancer Center of Colorado Springs

Colorado Springs, Colorado, United States

Site Status

Northern Hematology-Oncology

Thornton, Colorado, United States

Site Status

Lynn Regional Cancer Center

Boca Raton, Florida, United States

Site Status

New Hope Cancer Centers

Hudson, Florida, United States

Site Status

Oceola Cancer Center

Kissimmee, Florida, United States

Site Status

VA Medical Center

Miami, Florida, United States

Site Status

Innovative Medical Research of South Florida, Inc.

Miami Shores, Florida, United States

Site Status

NCH Healthcare System Oncology Research

Naples, Florida, United States

Site Status

Metcare Oncology

Ormond Beach, Florida, United States

Site Status

Hematology-Oncology Associates

Pensacola, Florida, United States

Site Status

AMIT SHAH Medical Group

Sebring, Florida, United States

Site Status

Peachtree Hematology & Oncology

Atlanta, Georgia, United States

Site Status

Emory University

Atlanta, Georgia, United States

Site Status

Straub Clinic & Hospital

Honolulu, Hawaii, United States

Site Status

Kaiser Foundation Hospital

Honolulu, Hawaii, United States

Site Status

Advocate Illinois Masonic Medical Center Creticos Cancer Center

Chicago, Illinois, United States

Site Status

OSF Center for Cancer Care

Rockford, Illinois, United States

Site Status

Springfield Clinic, LLP

Springfield, Illinois, United States

Site Status

Central Indiana Cancer Centers

Indianapolis, Indiana, United States

Site Status

Oncology Institute of Greater Lafayette

Lafayette, Indiana, United States

Site Status

Community Hospital, Cancer Research Dept.

Munster, Indiana, United States

Site Status

Northern Indiana Oncology Associates

South Bend, Indiana, United States

Site Status

Cedar Valley Medical Specialists

Waterloo, Iowa, United States

Site Status

Kansas City Cancer Ctr. South

Lenexa, Kansas, United States

Site Status

Hematology/Oncology Clinic

Baton Rouge, Louisiana, United States

Site Status

Mary Bird Perkins Cancer Center

Baton Rouge, Louisiana, United States

Site Status

LSU Health Sciences Center

Shreveport, Louisiana, United States

Site Status

Maine Center for Cancer Medicine

Scarborough, Maine, United States

Site Status

Oncology Care Associates

Bethesda, Maryland, United States

Site Status

Berkshire Hematology Oncology PC

Pittsfield, Massachusetts, United States

Site Status

Karmanos Cancer Institute

Detroit, Michigan, United States

Site Status

Kalamazoo Hematology & Oncology

Kalamazoo, Michigan, United States

Site Status

Mitchell Folbe, MD, PC

Troy, Michigan, United States

Site Status

Park Nicollett Institute

Saint Louis Park, Minnesota, United States

Site Status

St. Louis Cancer Care

Chesterfield, Missouri, United States

Site Status

Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

Site Status

Odyssey Research

Scottsbluff, Nebraska, United States

Site Status

Southern Nevada Cancer Research Foundation

Las Vegas, Nevada, United States

Site Status

Nevada Cancer Center

Las Vegas, Nevada, United States

Site Status

East Orange VA Medical System

East Orange, New Jersey, United States

Site Status

Howell Office Plaza

Howell Township, New Jersey, United States

Site Status

Atlantic Hem Onc Associates, LLC

Manasquan, New Jersey, United States

Site Status

Hematology/Oncology Assoc. of South Jersey

Mount Holly, New Jersey, United States

Site Status

Cancer Institute of New Jersey at Cooper University Hospital

Voorhees Township, New Jersey, United States

Site Status

New Mexico Oncology Hematology Consultants, Ltd.

Albuquerque, New Mexico, United States

Site Status

San Juan Regional Cancer Ctr.

Farmington, New Mexico, United States

Site Status

New Mexico Cancer Care Associates

Santa Fe, New Mexico, United States

Site Status

Engracio Cortes, MD

Bayside, New York, United States

Site Status

Arena Oncology Assoc.

Great Neck, New York, United States

Site Status

James P. Wilmot Cancer Center

Rochester, New York, United States

Site Status

SUNY Upstate Medical University

Syracuse, New York, United States

Site Status

Syracuse VA Medical Center

Syracuse, New York, United States

Site Status

Presbyterian Hospital

Charlotte, North Carolina, United States

Site Status

Southern Oncology Research

Grifton, North Carolina, United States

Site Status

Barberton Citizens Hospital-Cancer Center

Barberton, Ohio, United States

Site Status

Dayton Clinical Oncology Program

Dayton, Ohio, United States

Site Status

Forum Health Cancer CareCenter

Youngstown, Ohio, United States

Site Status

Cancer Specialists of Oklahoma

Oklahoma City, Oklahoma, United States

Site Status

Hematology Oncology Associates

Medford, Oregon, United States

Site Status

Charleston Hematology Oncology

Charleston, South Carolina, United States

Site Status

Charleston Cancer Center

Charleston, South Carolina, United States

Site Status

Liberty Hematology-Oncology

Columbia, South Carolina, United States

Site Status

Santee Hematology/Oncology

Sumter, South Carolina, United States

Site Status

The Jones Clinic

Germantown, Tennessee, United States

Site Status

Knoxville Cancer Center

Knoxville, Tennessee, United States

Site Status

Cancer Specialists of South Texas

Corpus Christi, Texas, United States

Site Status

Blood and Cancer Center of East Texas

Tyler, Texas, United States

Site Status

Tyler Hematology Oncology, PA

Tyler, Texas, United States

Site Status

Odyssey Research

Belle Haven, Virginia, United States

Site Status

Masoom Kandahari, MD

Woodbridge, Virginia, United States

Site Status

West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

References

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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.

Reference Type RESULT
PMID: 19493585 (View on PubMed)

Other Identifiers

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US 75

Identifier Type: -

Identifier Source: secondary_id

CZOL446EUS75

Identifier Type: -

Identifier Source: org_study_id

NCT00093717

Identifier Type: -

Identifier Source: nct_alias

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