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Completed Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT00085826

Public ClinicalTrials.gov record NCT00085826. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Sep 3, 2026, 9:25 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT00085826
Recruitment status
Completed
Study type
Interventional
Phase
Phase 3
Lead sponsor
Astellas Pharma Inc
Industry
Enrollment
600 participants

Conditions and interventions

Interventions

Drug

Eligibility (public fields only)

Age range
Not listed
Sex
Not listed
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Mar 31, 2001
Primary completion
Not listed
Completion
Nov 30, 2004
Last update posted
Oct 19, 2011

2001 – 2004

United States locations

U.S. sites
114
U.S. states
28
U.S. cities
95
Facility City State ZIP Site status
Birmingham Hematology Oncology Associates Birmingham Alabama 35205
Birmingham Hematology and Oncology Associates, LLC Birmingham Alabama 35235
Northern Arizona Hematology and Oncology Associates Flagstaff Arizona 86001
Hematology & Oncology Associates Phoenix Arizona 85012
Northern Arizona Hematology & Oncology Associates Sedona Arizona 86336
Arizona Clinical Research Center Tucson Arizona 85715
Arkansas Oncology Associates, PA Little Rock Arkansas 72207
Pacific Coast Hematology/Oncology Medical Group, Inc. Fountain Valley California 92708
California Cancer Care, Inc. Greenbrae California 94904
Scripps Cancer Center San Diego California 92121
Sharp Clinical Oncology Research San Diego California 92123
Redwood Regional Medical Group Santa Rosa California 95403
Rocky Mountain Cancer Center Boulder Colorado 80304
Rocky Mountain Cancer Centers Colorado Springs Colorado 80909
RMCC Denver Colorado 80218
12. Rocky Mountain Cancer Centers-Englewood Englewood Colorado 80110
Rocky Mountain Cancer Centers Englewood Colorado 80110
Rocky Mountain Cancer Centers Fort Collins Colorado 80524
Rocky Mountain Cancer Centers Littleton Colorado 80120
Rocky Mountain Cancer Centers Thornton Colorado 80260
Boca Raton Comprehensive Cancer Center Boca Raton Florida 33428
Comprehensive Cancer Care Specialists at Boca Raton Boca Raton Florida 33428
North Florida Hematology & Oncology Association Jacksonville Florida 32204
Florida Oncology Associates Jacksonville Florida 32207
South Florida Oncology & Hematology Consultants Lauderhill Florida 33319
Florida Cancer Institute New Port Richey Florida 34655
Ocala Oncology Center Ocala Florida 34474
Florida Oncology Associates Orange Park Florida 32073
Cancer Centers of Florida Orlando Florida 32806
Lauderhill Lakes Plantation Florida 33324
Evanston Northwestern Healthcare Evanston Illinois 60201
Northwest Medical Specialists, PC Niles Illinois 60714
Onc/Hem Associates of Central Illinois Peoria Illinois 61602
Hematology Oncology Associates of Illinois Skokie Illinois 60077
Central Indiana Cancer Centers Indianapolis Indiana 46227
Iowa Cancer Care, PLC Cedar Rapids Iowa 52403
Iowa Oncology Associates Cedar Rapids Iowa 52403
Central Maryland Oncology Center Columbia Maryland 21044
Central Maryland Oncology Group Towson Maryland 21204
Impath Predictive Oncology Franklin Massachusetts 02038
Minnesota Oncology Hematology, PA Minneapolis Minnesota 55404
Minnesota Oncology Hematology, PA Saint Paul Minnesota 55102
Missouri Cancer Associates Columbia Missouri 65201
Kansas City Oncology and Hematology Group Kansas City Missouri 64111
The Center for Cancer Care & Research St Louis Missouri 63141
Hematology Oncology Centers of the Northern Rockies Billings Montana 59101
New Mexico Cancer Center Associates Santa Fe New Mexico 87501
New York Oncology Hematology, PC Albany New York 12208
New York Oncology Hematology Albany New York 12208
HemOnCare, PC Brooklyn New York 11235
North Shore Hematology/Oncology Associates, P.C. East Setauket New York 11733
Cancer Research of Long Island Great Neck New York 11023
Interlakes Oncology & Hematology, P.C. Rochester New York 14623
Asheville Hematology & Oncology Associates, PA Asheville North Carolina 28801
Raleigh Hematology Oncology Clini Cary North Carolina 27511
Regional Hamatology Oncology Associates Durham North Carolina 27704
Northeastern Carolina Hematology & Oncology, PA Hickory North Carolina 28602
Raleigh Hematology Oncology Clinic Raleigh North Carolina 27607
Raleigh Hematology Oncology Clinic Raleigh North Carolina 27609
Piedmont Hematology Onccology Associates, P.A. Winston-Salem North Carolina 27103
Dayton Oncology/Hematology, PA Kettering Ohio 45409
Cancer Care Associates - Baptist Campus Oklahoma City Oklahoma 73112
Cancer Care Associates Tulsa Oklahoma 74136-1902
Willamette Valley Cancer Center Eugene Oregon 97401
Hematology & Oncolgy Assoc of NE PA Dunmore Pennsylvania 18512
Medical Oncology Associates of Wymoning Valley, PC Kingston Pennsylvania 18704
Thomas Jefferson University Hospital Philadelphia Pennsylvania 19107
Temple Cancer Center Philadelphia Pennsylvania 19140
Oncology-Hematology Associates Pittsburgh Pennsylvania 15215
Cancer Centers of the Carolinas Greenville South Carolina 29615
University of Tennessee Cancer Institute Memphis Tennessee 38104
Texas Oncology, PA Abilene Texas 79601-2301
Texas Oncology, P.A Arlington Texas 76012
South Austin Cancer Center Austin Texas 78745
Mamie McFadden Ward Cancer Center Beaumont Texas 77702-1449
Texas Oncology, P.A. Bedford Texas 76022
US Oncology Research Dallas Texas 75204
Texas Cancer Center at Medical City Dallas Texas 75230-2510
Texas Onclology, PA Dallas Texas 75231
The Texas Cancer Center - Dallas Southwest Dallas Texas 75237
Texas Oncology, PA Dallas Texas 75246
Texoma Cancer Center Denison Texas 75020-2088
Texas Cancer Center Fort Worth Texas 76104
Texas Oncology, PA Fort Worth Texas 76104
San Antonio Tumor and Blood Clinic Fredicksburg Texas 78624
Texas Oncology, PA Garland Texas 75042-5788
Texas Oncology, PA Houston Texas 77024
Texas Oncology, PA Houston Texas 77029
Texas Oncology, PA Houston Texas 77030
Texas Oncology, PA Houston Texas 77074-1811
Texas Oncology, PA Irving Texas 75061
Lake Vista Cancer Center Lewisville Texas 75067
Texas Cancer Center of Mesquite Mesquite Texas 75150
Allison Cancer Center Midland Texas 79701-5946
West Texas Cancer Center Odessa Texas 79761
an Antonio Tumor and Blood Clinic San Antonio Texas 78217
Hematology Oncology Associates of South Texas San Antonio Texas 78229
Not listed San Antonio Texas
Tyler Cancer Center Tyler Texas 75702
Waco Cancer Care & Research Center Waco Texas 76712
Deke Slayton Cancer Center Webster Texas 77589
Texoma Cancer Center Wichita Falls Texas 76310
Utah Cancer Specialists Salt Lake City Utah 84106
Fairfax Northern Virginia Hematology-Oncology, PC Fairfax Virginia 22031
Virginia Oncology Associates Newport News Virginia 23606
Virginia Oncology Associates Norfolk Virginia 23502
Oncology & Hematology Associates of South West Virginia, Inc. Salem Virginia 24153
Puget Sound Cancer Centers Edmonds Washington 98026
Ranier Oncology Professional Services Puyallup Washington 98372
Washington Cancer Center, P.C.Puget Sound Cancer Cente Seattle Washington 98133
Cancer Care Northwest Spokane Washington 99218
MultiCare Health System Tacoma Washington 98405
Northwest Cancer Specialists, PC Vancouver Washington 98684
University of Wisconsin Comprehensive Cancer Center Madison Wisconsin 53792

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT00085826, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Oct 19, 2011 · Synced Sep 3, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT00085826 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →