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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 Oct 18, 2026, 8:55 PM 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
Apr 2001 (Type not available)
Primary completion
Not listed
Completion
Dec 2004 (Actual)
Last update posted
Oct 20, 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 20, 2011 · Synced Oct 18, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT00085826 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →