Clinical trial NCT00085826: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Non-Small Cell Lung Cancer
Keywords: Lung Cancer
NSCLC
Non-small Cell Lung Cancer
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
Collaborators: name: OSI Pharmaceuticals
First posted: 2004-06-17
Enrollment: 600
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Exclusion Criteria:

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Hematology Oncology Associates
state: Alabama
city: Birmingham
country: United States
facility: Birmingham Hematology and Oncology Associates, LLC
state: Alabama
city: Flagstaff
country: United States
facility: Northern Arizona Hematology and Oncology Associates
state: Arizona
city: Phoenix
country: United States
facility: Hematology & Oncology Associates
state: Arizona
city: Sedona
country: United States
facility: Northern Arizona Hematology & Oncology Associates
state: Arizona
city: Tucson
country: United States
facility: Arizona Clinical Research Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Oncology Associates, PA
state: Arkansas
city: Fountain Valley
country: United States
facility: Pacific Coast Hematology/Oncology Medical Group, Inc.
state: California
city: Greenbrae
country: United States
facility: California Cancer Care, Inc.
state: California
city: San Diego
country: United States
facility: Sharp Clinical Oncology Research
state: California
city: SanDiego
country: United States
facility: Scripps Cancer Center
state: California
city: Santa Rosa
country: United States
facility: Redwood Regional Medical Group
state: California
city: Boulder
country: United States
facility: Rocky Mountain Cancer Center
state: Colorado
city: Colorado Springs
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Denver
country: United States
facility: RMCC
state: Colorado
city: Englewood
country: United States
facility: 12. Rocky Mountain Cancer Centers-Englewood
state: Colorado
city: Englewood
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Fort Collins
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Littleton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Thornton
country: United States
facility: Rocky Mountain Cancer Centers
state: Colorado
city: Boca Raton
country: United States
facility: Boca Raton Comprehensive Cancer Center
state: Florida
city: Boca Raton
country: United States
facility: Comprehensive Cancer Care Specialists at Boca Raton
state: Florida
city: Jacksonville
country: United States
facility: North Florida Hematology & Oncology Association
state: Florida
city: Jacksonville
country: United States
facility: Florida Oncology Associates
state: Florida
city: Lauderhill
country: United States
facility: South Florida Oncology & Hematology Consultants
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Institute
state: Florida
city: Ocala
country: United States
facility: Ocala Oncology Center
state: Florida
city: Orange Park
country: United States
facility: Florida Oncology Associates
state: Florida
city: Orlando
country: United States
facility: Cancer Centers of Florida
state: Florida
city: Plantation
country: United States
facility: Lauderhill Lakes
state: Florida
city: Evanston
country: United States
facility: Evanston Northwestern Healthcare
state: Illinois
city: Niles
country: United States
facility: Northwest Medical Specialists, PC
state: Illinois
city: Peoria
country: United States
facility: Onc/Hem Associates of Central Illinois
state: Illinois
city: Skokie
country: United States
facility: Hematology Oncology Associates of Illinois
state: Illinois
city: Indianapolis
country: United States
facility: Central Indiana Cancer Centers
state: Indiana
city: Cedar Rapids
country: United States
facility: Iowa Cancer Care, PLC
state: Iowa
city: Cedar Rapids
country: United States
facility: Iowa Oncology Associates
state: Iowa
city: Columbia
country: United States
facility: Central Maryland Oncology Center
state: Maryland
city: Towson
country: United States
facility: Central Maryland Oncology Group
state: Maryland
city: Franklin
country: United States
facility: Impath Predictive Oncology
state: Massachusetts
city: Minneapolis
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: St. Paul
country: United States
facility: Minnesota Oncology Hematology, PA
state: Minnesota
city: Columbia
country: United States
facility: Missouri Cancer Associates
state: Missouri
city: Kansas City
country: United States
facility: Kansas City Oncology and Hematology Group
state: Missouri
city: St. Louis
country: United States
facility: The Center for Cancer Care & Research
state: Missouri
city: Billings
country: United States
facility: Hematology Oncology Centers of the Northern Rockies
state: Montana
city: Santa Fe
country: United States
facility: New Mexico Cancer Center Associates
state: New Mexico
city: Albany
country: United States
facility: New York Oncology Hematology, PC
state: New York
city: Albany
country: United States
facility: New York Oncology Hematology
state: New York
city: Brooklyn
country: United States
facility: HemOnCare, PC
state: New York
city: East Setauket
country: United States
facility: North Shore Hematology/Oncology Associates, P.C.
state: New York
city: Great Neck
country: United States
facility: Cancer Research of Long Island
state: New York
city: Rochester
country: United States
facility: Interlakes Oncology & Hematology, P.C.
state: New York
city: Asheville
country: United States
facility: Asheville Hematology & Oncology Associates, PA
state: North Carolina
city: Cary
country: United States
facility: Raleigh Hematology Oncology Clini
state: North Carolina
city: Durham
country: United States
facility: Regional Hamatology Oncology Associates
state: North Carolina
city: Hickory
country: United States
facility: Northeastern Carolina Hematology & Oncology, PA
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Raleigh
country: United States
facility: Raleigh Hematology Oncology Clinic
state: North Carolina
city: Winston-Salem
country: United States
facility: Piedmont Hematology Onccology Associates, P.A.
state: North Carolina
city: Kettering
country: United States
facility: Dayton Oncology/Hematology, PA
state: Ohio
city: Oklahoma City
country: United States
facility: Cancer Care Associates - Baptist Campus
state: Oklahoma
city: Tulsa
country: United States
facility: Cancer Care Associates
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Cancer Center
state: Oregon
city: Dunmore
country: United States
facility: Hematology & Oncolgy Assoc of NE PA
state: Pennsylvania
city: Kingston
country: United States
facility: Medical Oncology Associates of Wymoning Valley, PC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple Cancer Center
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Oncology-Hematology Associates
state: Pennsylvania
city: Greenville
country: United States
facility: Cancer Centers of the Carolinas
state: South Carolina
city: Memphis
country: United States
facility: University of Tennessee Cancer Institute
state: Tennessee
city: Abilene
country: United States
facility: Texas Oncology, PA
state: Texas
city: Arlington
country: United States
facility: Texas Oncology, P.A
state: Texas
city: Austin
country: United States
facility: South Austin Cancer Center
state: Texas
city: Beaumont
country: United States
facility: Mamie McFadden Ward Cancer Center
state: Texas
city: Bedford
country: United States
facility: Texas Oncology, P.A.
state: Texas
city: Dallas
country: United States
facility: US Oncology Research
state: Texas
city: Dallas
country: United States
facility: Texas Cancer Center at Medical City
state: Texas
city: Dallas
country: United States
facility: Texas Onclology, PA
state: Texas
city: Dallas
country: United States
facility: The Texas Cancer Center - Dallas Southwest
state: Texas
city: Dallas
country: United States
facility: Texas Oncology, PA
state: Texas
city: Denison
country: United States
facility: Texoma Cancer Center
state: Texas
city: Fort Worth
country: United States
facility: Texas Oncology, PA
state: Texas
city: Fredicksburg
country: United States
facility: San Antonio Tumor and Blood Clinic
state: Texas
city: Ft. Worth
country: United States
facility: Texas Cancer Center
state: Texas
city: Garland
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Houston
country: United States
facility: Texas Oncology, PA
state: Texas
city: Irving
country: United States
facility: Texas Oncology, PA
state: Texas
city: Lewisville
country: United States
facility: Lake Vista Cancer Center
state: Texas
city: Mesquite
country: United States
facility: Texas Cancer Center of Mesquite
state: Texas
city: Midland
country: United States
facility: Allison Cancer Center
state: Texas
city: Odessa
country: United States
facility: West Texas Cancer Center
state: Texas
city: San Antonio
country: United States
facility: an Antonio Tumor and Blood Clinic
state: Texas
city: San Antonio
country: United States
facility: Hematology Oncology Associates of South Texas
state: Texas
city: San Antonio
country: United States
state: Texas
city: Tyler
country: United States
facility: Tyler Cancer Center
state: Texas
city: Waco
country: United States
facility: Waco Cancer Care & Research Center
state: Texas
city: Webster
country: United States
facility: Deke Slayton Cancer Center
state: Texas
city: Wichita Falls
country: United States
facility: Texoma Cancer Center
state: Texas
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Fairfax
country: United States
facility: Fairfax Northern Virginia Hematology-Oncology, PC
state: Virginia
city: Newport News
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Norfolk
country: United States
facility: Virginia Oncology Associates
state: Virginia
city: Salem
country: United States
facility: Oncology & Hematology Associates of South West Virginia, Inc.
state: Virginia
city: Edmonds
country: United States
facility: Puget Sound Cancer Centers
state: Washington
city: Puyallup
country: United States
facility: Ranier Oncology Professional Services
state: Washington
city: Seattle
country: United States
facility: Washington Cancer Center, P.C.Puget Sound Cancer Cente
state: Washington
city: Spokane
country: United States
facility: Cancer Care Northwest
state: Washington
city: Tacoma
country: United States
facility: MultiCare Health System
state: Washington
city: Vancouver
country: United States
facility: Northwest Cancer Specialists, PC
state: Washington
city: Madison
country: United States
facility: University of Wisconsin Comprehensive Cancer Center
state: Wisconsin
Study officials:
References: