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A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients

Primary Purpose

Non-Small Cell Lung Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Exisulind
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-Small Cell Lung Cancer focused on measuring Lung Cancer, NSCLC, Non-small Cell Lung Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)Does not accept healthy volunteers

Exclusion Criteria:

Sites / Locations

  • Birmingham Hematology Oncology Associates
  • Birmingham Hematology and Oncology Associates, LLC
  • Northern Arizona Hematology and Oncology Associates
  • Hematology & Oncology Associates
  • Northern Arizona Hematology & Oncology Associates
  • Arizona Clinical Research Center
  • Arkansas Oncology Associates, PA
  • Pacific Coast Hematology/Oncology Medical Group, Inc.
  • California Cancer Care, Inc.
  • Sharp Clinical Oncology Research
  • Scripps Cancer Center
  • Redwood Regional Medical Group
  • Rocky Mountain Cancer Center
  • Rocky Mountain Cancer Centers
  • RMCC
  • 12. Rocky Mountain Cancer Centers-Englewood
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Rocky Mountain Cancer Centers
  • Boca Raton Comprehensive Cancer Center
  • Comprehensive Cancer Care Specialists at Boca Raton
  • North Florida Hematology & Oncology Association
  • Florida Oncology Associates
  • South Florida Oncology & Hematology Consultants
  • Florida Cancer Institute
  • Ocala Oncology Center
  • Florida Oncology Associates
  • Cancer Centers of Florida
  • Lauderhill Lakes
  • Evanston Northwestern Healthcare
  • Northwest Medical Specialists, PC
  • Onc/Hem Associates of Central Illinois
  • Hematology Oncology Associates of Illinois
  • Central Indiana Cancer Centers
  • Iowa Cancer Care, PLC
  • Iowa Oncology Associates
  • Central Maryland Oncology Center
  • Central Maryland Oncology Group
  • Impath Predictive Oncology
  • Minnesota Oncology Hematology, PA
  • Minnesota Oncology Hematology, PA
  • Missouri Cancer Associates
  • Kansas City Oncology and Hematology Group
  • The Center for Cancer Care & Research
  • Hematology Oncology Centers of the Northern Rockies
  • New Mexico Cancer Center Associates
  • New York Oncology Hematology, PC
  • New York Oncology Hematology
  • HemOnCare, PC
  • North Shore Hematology/Oncology Associates, P.C.
  • Cancer Research of Long Island
  • Interlakes Oncology & Hematology, P.C.
  • Asheville Hematology & Oncology Associates, PA
  • Raleigh Hematology Oncology Clini
  • Regional Hamatology Oncology Associates
  • Northeastern Carolina Hematology & Oncology, PA
  • Raleigh Hematology Oncology Clinic
  • Raleigh Hematology Oncology Clinic
  • Piedmont Hematology Onccology Associates, P.A.
  • Dayton Oncology/Hematology, PA
  • Cancer Care Associates - Baptist Campus
  • Cancer Care Associates
  • Willamette Valley Cancer Center
  • Hematology & Oncolgy Assoc of NE PA
  • Medical Oncology Associates of Wymoning Valley, PC
  • Thomas Jefferson University Hospital
  • Temple Cancer Center
  • Oncology-Hematology Associates
  • Cancer Centers of the Carolinas
  • University of Tennessee Cancer Institute
  • Texas Oncology, PA
  • Texas Oncology, P.A
  • South Austin Cancer Center
  • Mamie McFadden Ward Cancer Center
  • Texas Oncology, P.A.
  • US Oncology Research
  • Texas Cancer Center at Medical City
  • Texas Onclology, PA
  • The Texas Cancer Center - Dallas Southwest
  • Texas Oncology, PA
  • Texoma Cancer Center
  • Texas Oncology, PA
  • San Antonio Tumor and Blood Clinic
  • Texas Cancer Center
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Texas Oncology, PA
  • Lake Vista Cancer Center
  • Texas Cancer Center of Mesquite
  • Allison Cancer Center
  • West Texas Cancer Center
  • an Antonio Tumor and Blood Clinic
  • Hematology Oncology Associates of South Texas
  • Tyler Cancer Center
  • Waco Cancer Care & Research Center
  • Deke Slayton Cancer Center
  • Texoma Cancer Center
  • Utah Cancer Specialists
  • Fairfax Northern Virginia Hematology-Oncology, PC
  • Virginia Oncology Associates
  • Virginia Oncology Associates
  • Oncology & Hematology Associates of South West Virginia, Inc.
  • Puget Sound Cancer Centers
  • Ranier Oncology Professional Services
  • Washington Cancer Center, P.C.Puget Sound Cancer Cente
  • Cancer Care Northwest
  • MultiCare Health System
  • Northwest Cancer Specialists, PC
  • University of Wisconsin Comprehensive Cancer Center

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 15, 2004
Last Updated
October 18, 2011
Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT00085826
Brief Title
A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients
Official Title
A Phase III, Randomized, Double-Blind, Multi-Center Study of the Efficacy of Taxotere (Docetaxel) in Combination With Aptosyn (Exisulind) Versus Taxotere (Docetaxel) and Placebo in Non-Small Cell Lung Cancer (NSCLC) Patients After Failure of Prior Platinum-Based Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
Collaborators
OSI Pharmaceuticals

4. Oversight

5. Study Description

Brief Summary
Taxotere has been approved by the FDA and is considered a standard treatment for patients with lung cancer who have failed prior platinum-containing regimens. The main purpose of this research study is to determine if Aptosyn, when given in combination with Taxotere, will result in prolonged survival when compared to Taxotere alone. This study will also help determine tumor response rates, and the safety profile of Aptosyn in combination with Taxotere. This study has been completed and a publication is pending.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Small Cell Lung Cancer
Keywords
Lung Cancer, NSCLC, Non-small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
600 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Exisulind

10. Eligibility

Accepts Healthy Volunteers
No
Eligibility Criteria
Exclusion Criteria:
Facility Information:
Facility Name
Birmingham Hematology Oncology Associates
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Birmingham Hematology and Oncology Associates, LLC
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35235
Country
United States
Facility Name
Northern Arizona Hematology and Oncology Associates
City
Flagstaff
State/Province
Arizona
ZIP/Postal Code
86001
Country
United States
Facility Name
Hematology & Oncology Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Northern Arizona Hematology & Oncology Associates
City
Sedona
State/Province
Arizona
ZIP/Postal Code
86336
Country
United States
Facility Name
Arizona Clinical Research Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Arkansas Oncology Associates, PA
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72207
Country
United States
Facility Name
Pacific Coast Hematology/Oncology Medical Group, Inc.
City
Fountain Valley
State/Province
California
ZIP/Postal Code
92708
Country
United States
Facility Name
California Cancer Care, Inc.
City
Greenbrae
State/Province
California
ZIP/Postal Code
94904
Country
United States
Facility Name
Sharp Clinical Oncology Research
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Scripps Cancer Center
City
SanDiego
State/Province
California
ZIP/Postal Code
92121
Country
United States
Facility Name
Redwood Regional Medical Group
City
Santa Rosa
State/Province
California
ZIP/Postal Code
95403
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
RMCC
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
12. Rocky Mountain Cancer Centers-Englewood
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80524
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Littleton
State/Province
Colorado
ZIP/Postal Code
80120
Country
United States
Facility Name
Rocky Mountain Cancer Centers
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80260
Country
United States
Facility Name
Boca Raton Comprehensive Cancer Center
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
Comprehensive Cancer Care Specialists at Boca Raton
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33428
Country
United States
Facility Name
North Florida Hematology & Oncology Association
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32204
Country
United States
Facility Name
Florida Oncology Associates
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
South Florida Oncology & Hematology Consultants
City
Lauderhill
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Florida Cancer Institute
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Ocala Oncology Center
City
Ocala
State/Province
Florida
ZIP/Postal Code
34474
Country
United States
Facility Name
Florida Oncology Associates
City
Orange Park
State/Province
Florida
ZIP/Postal Code
32073
Country
United States
Facility Name
Cancer Centers of Florida
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Lauderhill Lakes
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Facility Name
Evanston Northwestern Healthcare
City
Evanston
State/Province
Illinois
ZIP/Postal Code
60201
Country
United States
Facility Name
Northwest Medical Specialists, PC
City
Niles
State/Province
Illinois
ZIP/Postal Code
60714
Country
United States
Facility Name
Onc/Hem Associates of Central Illinois
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Hematology Oncology Associates of Illinois
City
Skokie
State/Province
Illinois
ZIP/Postal Code
60077
Country
United States
Facility Name
Central Indiana Cancer Centers
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46227
Country
United States
Facility Name
Iowa Cancer Care, PLC
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Iowa Oncology Associates
City
Cedar Rapids
State/Province
Iowa
ZIP/Postal Code
52403
Country
United States
Facility Name
Central Maryland Oncology Center
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21044
Country
United States
Facility Name
Central Maryland Oncology Group
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Impath Predictive Oncology
City
Franklin
State/Province
Massachusetts
ZIP/Postal Code
02038
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55404
Country
United States
Facility Name
Minnesota Oncology Hematology, PA
City
St. Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Missouri Cancer Associates
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65201
Country
United States
Facility Name
Kansas City Oncology and Hematology Group
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
The Center for Cancer Care & Research
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Hematology Oncology Centers of the Northern Rockies
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
New Mexico Cancer Center Associates
City
Santa Fe
State/Province
New Mexico
ZIP/Postal Code
87501
Country
United States
Facility Name
New York Oncology Hematology, PC
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
New York Oncology Hematology
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
HemOnCare, PC
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
North Shore Hematology/Oncology Associates, P.C.
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Cancer Research of Long Island
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Interlakes Oncology & Hematology, P.C.
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
Asheville Hematology & Oncology Associates, PA
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Raleigh Hematology Oncology Clini
City
Cary
State/Province
North Carolina
ZIP/Postal Code
27511
Country
United States
Facility Name
Regional Hamatology Oncology Associates
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27704
Country
United States
Facility Name
Northeastern Carolina Hematology & Oncology, PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Raleigh Hematology Oncology Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Raleigh Hematology Oncology Clinic
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27609
Country
United States
Facility Name
Piedmont Hematology Onccology Associates, P.A.
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Dayton Oncology/Hematology, PA
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Cancer Care Associates - Baptist Campus
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Cancer Care Associates
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136-1902
Country
United States
Facility Name
Willamette Valley Cancer Center
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Hematology & Oncolgy Assoc of NE PA
City
Dunmore
State/Province
Pennsylvania
ZIP/Postal Code
18512
Country
United States
Facility Name
Medical Oncology Associates of Wymoning Valley, PC
City
Kingston
State/Province
Pennsylvania
ZIP/Postal Code
18704
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Oncology-Hematology Associates
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15215
Country
United States
Facility Name
Cancer Centers of the Carolinas
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
University of Tennessee Cancer Institute
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
Texas Oncology, PA
City
Abilene
State/Province
Texas
ZIP/Postal Code
79601-2301
Country
United States
Facility Name
Texas Oncology, P.A
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
South Austin Cancer Center
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Mamie McFadden Ward Cancer Center
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77702-1449
Country
United States
Facility Name
Texas Oncology, P.A.
City
Bedford
State/Province
Texas
ZIP/Postal Code
76022
Country
United States
Facility Name
US Oncology Research
City
Dallas
State/Province
Texas
ZIP/Postal Code
75204
Country
United States
Facility Name
Texas Cancer Center at Medical City
City
Dallas
State/Province
Texas
ZIP/Postal Code
75230-2510
Country
United States
Facility Name
Texas Onclology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
The Texas Cancer Center - Dallas Southwest
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
Texas Oncology, PA
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
Texoma Cancer Center
City
Denison
State/Province
Texas
ZIP/Postal Code
75020-2088
Country
United States
Facility Name
Texas Oncology, PA
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
San Antonio Tumor and Blood Clinic
City
Fredicksburg
State/Province
Texas
ZIP/Postal Code
78624
Country
United States
Facility Name
Texas Cancer Center
City
Ft. Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Texas Oncology, PA
City
Garland
State/Province
Texas
ZIP/Postal Code
75042-5788
Country
United States
Facility Name
Texas Oncology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Texas Oncology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77029
Country
United States
Facility Name
Texas Oncology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Oncology, PA
City
Houston
State/Province
Texas
ZIP/Postal Code
77074-1811
Country
United States
Facility Name
Texas Oncology, PA
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Lake Vista Cancer Center
City
Lewisville
State/Province
Texas
ZIP/Postal Code
75067
Country
United States
Facility Name
Texas Cancer Center of Mesquite
City
Mesquite
State/Province
Texas
ZIP/Postal Code
75150
Country
United States
Facility Name
Allison Cancer Center
City
Midland
State/Province
Texas
ZIP/Postal Code
79701-5946
Country
United States
Facility Name
West Texas Cancer Center
City
Odessa
State/Province
Texas
ZIP/Postal Code
79761
Country
United States
Facility Name
an Antonio Tumor and Blood Clinic
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
Hematology Oncology Associates of South Texas
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
Facility Name
Tyler Cancer Center
City
Tyler
State/Province
Texas
ZIP/Postal Code
75702
Country
United States
Facility Name
Waco Cancer Care & Research Center
City
Waco
State/Province
Texas
ZIP/Postal Code
76712
Country
United States
Facility Name
Deke Slayton Cancer Center
City
Webster
State/Province
Texas
ZIP/Postal Code
77589
Country
United States
Facility Name
Texoma Cancer Center
City
Wichita Falls
State/Province
Texas
ZIP/Postal Code
76310
Country
United States
Facility Name
Utah Cancer Specialists
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84106
Country
United States
Facility Name
Fairfax Northern Virginia Hematology-Oncology, PC
City
Fairfax
State/Province
Virginia
ZIP/Postal Code
22031
Country
United States
Facility Name
Virginia Oncology Associates
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Virginia Oncology Associates
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Oncology & Hematology Associates of South West Virginia, Inc.
City
Salem
State/Province
Virginia
ZIP/Postal Code
24153
Country
United States
Facility Name
Puget Sound Cancer Centers
City
Edmonds
State/Province
Washington
ZIP/Postal Code
98026
Country
United States
Facility Name
Ranier Oncology Professional Services
City
Puyallup
State/Province
Washington
ZIP/Postal Code
98372
Country
United States
Facility Name
Washington Cancer Center, P.C.Puget Sound Cancer Cente
City
Seattle
State/Province
Washington
ZIP/Postal Code
98133
Country
United States
Facility Name
Cancer Care Northwest
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
MultiCare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Northwest Cancer Specialists, PC
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

Learn more about this trial

A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients

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