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

Primary Purpose

Non Small Cell Lung Carcinoma

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
zoledronic acid
Taxotere
Carboplatin
Sponsored by
Novartis Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Non Small Cell Lung Carcinoma focused on measuring lung cancer, ZPACT, US75, Bone Metastases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinical Research Consultants
  • Arizona Oncology Assoc.
  • NEA Clinic
  • Highlands Oncology Group
  • NorthBay Cancer Center
  • UCLA
  • Clinical Trials and Research Associates, Inc.
  • Med. Oncology Care Associates
  • Cancer Center of Santa Barbara
  • Cancer Center of Colorado Springs
  • Northern Hematology-Oncology
  • Lynn Regional Cancer Center
  • New Hope Cancer Centers
  • Oceola Cancer Center
  • Innovative Medical Research of South Florida, Inc.
  • VA Medical Center
  • NCH Healthcare System Oncology Research
  • Metcare Oncology
  • Hematology-Oncology Associates
  • AMIT SHAH Medical Group
  • Peachtree Hematology & Oncology
  • Emory University
  • Straub Clinic & Hospital
  • Kaiser Foundation Hospital
  • Advocate Illinois Masonic Medical Center Creticos Cancer Center
  • OSF Center for Cancer Care
  • Springfield Clinic, LLP
  • Central Indiana Cancer Centers
  • Oncology Institute of Greater Lafayette
  • Community Hospital, Cancer Research Dept.
  • Northern Indiana Oncology Associates
  • Cedar Valley Medical Specialists
  • Kansas City Cancer Ctr. South
  • Hematology/Oncology Clinic
  • Mary Bird Perkins Cancer Center
  • LSU Health Sciences Center
  • Maine Center for Cancer Medicine
  • Oncology Care Associates
  • Berkshire Hematology Oncology PC
  • Karmanos Cancer Institute
  • Kalamazoo Hematology & Oncology
  • Mitchell Folbe, MD, PC
  • Park Nicollett Institute
  • St. Louis Cancer Care
  • Southeast Nebraska Cancer Center
  • Odyssey Research
  • Southern Nevada Cancer Research Foundation
  • Nevada Cancer Center
  • East Orange VA Medical System
  • Howell Office Plaza
  • Atlantic Hem Onc Associates, LLC
  • Hematology/Oncology Assoc. of South Jersey
  • Cancer Institute of New Jersey at Cooper University Hospital
  • New Mexico Oncology Hematology Consultants, Ltd.
  • San Juan Regional Cancer Ctr.
  • New Mexico Cancer Care Associates
  • Engracio Cortes, MD
  • Arena Oncology Assoc.
  • James P. Wilmot Cancer Center
  • SUNY Upstate Medical University
  • Syracuse VA Medical Center
  • Presbyterian Hospital
  • Southern Oncology Research
  • Barberton Citizens Hospital-Cancer Center
  • Dayton Clinical Oncology Program
  • Forum Health Cancer CareCenter
  • Cancer Specialists of Oklahoma
  • Hematology Oncology Associates
  • Charleston Hematology Oncology
  • Charleston Cancer Center
  • Liberty Hematology-Oncology
  • Santee Hematology/Oncology
  • The Jones Clinic
  • Knoxville Cancer Center
  • Cancer Specialists of South Texas
  • Blood and Cancer Center of East Texas
  • Tyler Hematology Oncology, PA
  • Odyssey Research
  • Masoom Kandahari, MD
  • West Virginia University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Zometa®

no further treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 29, 2004
Last Updated
September 12, 2017
Sponsor
Novartis Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00086268
Brief Title
Non-small Cell Lung Cancer Study US75 (Z-PACT)
Acronym
ZPACT
Study Type
Interventional

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
April 2004 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Pharmaceuticals

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non Small Cell Lung Carcinoma
Keywords
lung cancer, ZPACT, US75, Bone Metastases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Zometa®
Arm Type
Experimental
Arm Description
4mg monthly for 12 months from date of first chemotherapy dose
Arm Title
no further treatment
Arm Type
No Intervention
Arm Description
Control arm; no further treatment. Follow-up monthly for 12 months from date of first chemotherapy dose
Intervention Type
Drug
Intervention Name(s)
zoledronic acid
Intervention Type
Drug
Intervention Name(s)
Taxotere
Intervention Type
Drug
Intervention Name(s)
Carboplatin

10. Eligibility

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

12. IPD Sharing Statement

Citations:
PubMed Identifier
19493585
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.
Results Reference
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Non-small Cell Lung Cancer Study US75 (Z-PACT)

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