A Phase III Study of the Efficacy of Taxotere/Aptosyn Versus Taxotere/Placebo in Non-Small Cell Lung Cancer Patients
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
1 other identifier
interventional
600
1 country
114
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 nonsmall-cell-lung-cancer
Started Apr 2001
114 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2001
CompletedFirst Submitted
Initial submission to the registry
June 15, 2004
CompletedFirst Posted
Study publicly available on registry
June 17, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2004
CompletedOctober 20, 2011
October 1, 2011
June 15, 2004
October 18, 2011
Conditions
Keywords
Interventions
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Astellas Pharma Inclead
- OSI Pharmaceuticalscollaborator
Study Sites (114)
Birmingham Hematology Oncology Associates
Birmingham, Alabama, 35205, United States
Birmingham Hematology and Oncology Associates, LLC
Birmingham, Alabama, 35235, United States
Northern Arizona Hematology and Oncology Associates
Flagstaff, Arizona, 86001, United States
Hematology & Oncology Associates
Phoenix, Arizona, 85012, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336, United States
Arizona Clinical Research Center
Tucson, Arizona, 85715, United States
Arkansas Oncology Associates, PA
Little Rock, Arkansas, 72207, United States
Pacific Coast Hematology/Oncology Medical Group, Inc.
Fountain Valley, California, 92708, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
Scripps Cancer Center
San Diego, California, 92121, United States
Sharp Clinical Oncology Research
San Diego, California, 92123, United States
Redwood Regional Medical Group
Santa Rosa, California, 95403, United States
Rocky Mountain Cancer Center
Boulder, Colorado, 80304, United States
Rocky Mountain Cancer Centers
Colorado Springs, Colorado, 80909, United States
RMCC
Denver, Colorado, 80218, United States
12. Rocky Mountain Cancer Centers-Englewood
Englewood, Colorado, 80110, United States
Rocky Mountain Cancer Centers
Englewood, Colorado, 80110, United States
Rocky Mountain Cancer Centers
Fort Collins, Colorado, 80524, United States
Rocky Mountain Cancer Centers
Littleton, Colorado, 80120, United States
Rocky Mountain Cancer Centers
Thornton, Colorado, 80260, United States
Boca Raton Comprehensive Cancer Center
Boca Raton, Florida, 33428, United States
Comprehensive Cancer Care Specialists at Boca Raton
Boca Raton, Florida, 33428, United States
North Florida Hematology & Oncology Association
Jacksonville, Florida, 32204, United States
Florida Oncology Associates
Jacksonville, Florida, 32207, United States
South Florida Oncology & Hematology Consultants
Lauderhill, Florida, 33319, United States
Florida Cancer Institute
New Port Richey, Florida, 34655, United States
Ocala Oncology Center
Ocala, Florida, 34474, United States
Florida Oncology Associates
Orange Park, Florida, 32073, United States
Cancer Centers of Florida
Orlando, Florida, 32806, United States
Lauderhill Lakes
Plantation, Florida, 33324, United States
Evanston Northwestern Healthcare
Evanston, Illinois, 60201, United States
Northwest Medical Specialists, PC
Niles, Illinois, 60714, United States
Onc/Hem Associates of Central Illinois
Peoria, Illinois, 61602, United States
Hematology Oncology Associates of Illinois
Skokie, Illinois, 60077, United States
Central Indiana Cancer Centers
Indianapolis, Indiana, 46227, United States
Iowa Cancer Care, PLC
Cedar Rapids, Iowa, 52403, United States
Iowa Oncology Associates
Cedar Rapids, Iowa, 52403, United States
Central Maryland Oncology Center
Columbia, Maryland, 21044, United States
Central Maryland Oncology Group
Towson, Maryland, 21204, United States
Impath Predictive Oncology
Franklin, Massachusetts, 02038, United States
Minnesota Oncology Hematology, PA
Minneapolis, Minnesota, 55404, United States
Minnesota Oncology Hematology, PA
Saint Paul, Minnesota, 55102, United States
Missouri Cancer Associates
Columbia, Missouri, 65201, United States
Kansas City Oncology and Hematology Group
Kansas City, Missouri, 64111, United States
The Center for Cancer Care & Research
St Louis, Missouri, 63141, United States
Hematology Oncology Centers of the Northern Rockies
Billings, Montana, 59101, United States
New Mexico Cancer Center Associates
Santa Fe, New Mexico, 87501, United States
New York Oncology Hematology, PC
Albany, New York, 12208, United States
New York Oncology Hematology
Albany, New York, 12208, United States
HemOnCare, PC
Brooklyn, New York, 11235, United States
North Shore Hematology/Oncology Associates, P.C.
East Setauket, New York, 11733, United States
Cancer Research of Long Island
Great Neck, New York, 11023, United States
Interlakes Oncology & Hematology, P.C.
Rochester, New York, 14623, United States
Asheville Hematology & Oncology Associates, PA
Asheville, North Carolina, 28801, United States
Raleigh Hematology Oncology Clini
Cary, North Carolina, 27511, United States
Regional Hamatology Oncology Associates
Durham, North Carolina, 27704, United States
Northeastern Carolina Hematology & Oncology, PA
Hickory, North Carolina, 28602, United States
Raleigh Hematology Oncology Clinic
Raleigh, North Carolina, 27607, United States
Raleigh Hematology Oncology Clinic
Raleigh, North Carolina, 27609, United States
Piedmont Hematology Onccology Associates, P.A.
Winston-Salem, North Carolina, 27103, United States
Dayton Oncology/Hematology, PA
Kettering, Ohio, 45409, United States
Cancer Care Associates - Baptist Campus
Oklahoma City, Oklahoma, 73112, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136-1902, United States
Willamette Valley Cancer Center
Eugene, Oregon, 97401, United States
Hematology & Oncolgy Assoc of NE PA
Dunmore, Pennsylvania, 18512, United States
Medical Oncology Associates of Wymoning Valley, PC
Kingston, Pennsylvania, 18704, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple Cancer Center
Philadelphia, Pennsylvania, 19140, United States
Oncology-Hematology Associates
Pittsburgh, Pennsylvania, 15215, United States
Cancer Centers of the Carolinas
Greenville, South Carolina, 29615, United States
University of Tennessee Cancer Institute
Memphis, Tennessee, 38104, United States
Texas Oncology, PA
Abilene, Texas, 79601-2301, United States
Texas Oncology, P.A
Arlington, Texas, 76012, United States
South Austin Cancer Center
Austin, Texas, 78745, United States
Mamie McFadden Ward Cancer Center
Beaumont, Texas, 77702-1449, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
US Oncology Research
Dallas, Texas, 75204, United States
Texas Cancer Center at Medical City
Dallas, Texas, 75230-2510, United States
Texas Onclology, PA
Dallas, Texas, 75231, United States
The Texas Cancer Center - Dallas Southwest
Dallas, Texas, 75237, United States
Texas Oncology, PA
Dallas, Texas, 75246, United States
Texoma Cancer Center
Denison, Texas, 75020-2088, United States
Texas Cancer Center
Fort Worth, Texas, 76104, United States
Texas Oncology, PA
Fort Worth, Texas, 76104, United States
San Antonio Tumor and Blood Clinic
Fredicksburg, Texas, 78624, United States
Texas Oncology, PA
Garland, Texas, 75042-5788, United States
Texas Oncology, PA
Houston, Texas, 77024, United States
Texas Oncology, PA
Houston, Texas, 77029, United States
Texas Oncology, PA
Houston, Texas, 77030, United States
Texas Oncology, PA
Houston, Texas, 77074-1811, United States
Texas Oncology, PA
Irving, Texas, 75061, United States
Lake Vista Cancer Center
Lewisville, Texas, 75067, United States
Texas Cancer Center of Mesquite
Mesquite, Texas, 75150, United States
Allison Cancer Center
Midland, Texas, 79701-5946, United States
West Texas Cancer Center
Odessa, Texas, 79761, United States
an Antonio Tumor and Blood Clinic
San Antonio, Texas, 78217, United States
Hematology Oncology Associates of South Texas
San Antonio, Texas, 78229, United States
Unknown Facility
San Antonio, Texas, United States
Tyler Cancer Center
Tyler, Texas, 75702, United States
Waco Cancer Care & Research Center
Waco, Texas, 76712, United States
Deke Slayton Cancer Center
Webster, Texas, 77589, United States
Texoma Cancer Center
Wichita Falls, Texas, 76310, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Fairfax Northern Virginia Hematology-Oncology, PC
Fairfax, Virginia, 22031, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Oncology & Hematology Associates of South West Virginia, Inc.
Salem, Virginia, 24153, United States
Puget Sound Cancer Centers
Edmonds, Washington, 98026, United States
Ranier Oncology Professional Services
Puyallup, Washington, 98372, United States
Washington Cancer Center, P.C.Puget Sound Cancer Cente
Seattle, Washington, 98133, United States
Cancer Care Northwest
Spokane, Washington, 99218, United States
MultiCare Health System
Tacoma, Washington, 98405, United States
Northwest Cancer Specialists, PC
Vancouver, Washington, 98684, United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 15, 2004
First Posted
June 17, 2004
Study Start
April 1, 2001
Study Completion
December 1, 2004
Last Updated
October 20, 2011
Record last verified: 2011-10