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

NCT ID: NCT00085826

Last Updated: 2011-10-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2001-04-30

Study Completion Date

2004-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Non-Small Cell Lung Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exisulind

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Exclusion Criteria:
Eligible Sex

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

OSI Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Birmingham Hematology Oncology Associates

Birmingham, Alabama, United States

Site Status

Birmingham Hematology and Oncology Associates, LLC

Birmingham, Alabama, United States

Site Status

Northern Arizona Hematology and Oncology Associates

Flagstaff, Arizona, United States

Site Status

Hematology & Oncology Associates

Phoenix, Arizona, United States

Site Status

Northern Arizona Hematology & Oncology Associates

Sedona, Arizona, United States

Site Status

Arizona Clinical Research Center

Tucson, Arizona, United States

Site Status

Arkansas Oncology Associates, PA

Little Rock, Arkansas, United States

Site Status

Pacific Coast Hematology/Oncology Medical Group, Inc.

Fountain Valley, California, United States

Site Status

California Cancer Care, Inc.

Greenbrae, California, United States

Site Status

Scripps Cancer Center

San Diego, California, United States

Site Status

Sharp Clinical Oncology Research

San Diego, California, United States

Site Status

Redwood Regional Medical Group

Santa Rosa, California, United States

Site Status

Rocky Mountain Cancer Center

Boulder, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Colorado Springs, Colorado, United States

Site Status

RMCC

Denver, Colorado, United States

Site Status

12. Rocky Mountain Cancer Centers-Englewood

Englewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Englewood, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Fort Collins, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Site Status

Rocky Mountain Cancer Centers

Thornton, Colorado, United States

Site Status

Boca Raton Comprehensive Cancer Center

Boca Raton, Florida, United States

Site Status

Comprehensive Cancer Care Specialists at Boca Raton

Boca Raton, Florida, United States

Site Status

North Florida Hematology & Oncology Association

Jacksonville, Florida, United States

Site Status

Florida Oncology Associates

Jacksonville, Florida, United States

Site Status

South Florida Oncology & Hematology Consultants

Lauderhill, Florida, United States

Site Status

Florida Cancer Institute

New Port Richey, Florida, United States

Site Status

Ocala Oncology Center

Ocala, Florida, United States

Site Status

Florida Oncology Associates

Orange Park, Florida, United States

Site Status

Cancer Centers of Florida

Orlando, Florida, United States

Site Status

Lauderhill Lakes

Plantation, Florida, United States

Site Status

Evanston Northwestern Healthcare

Evanston, Illinois, United States

Site Status

Northwest Medical Specialists, PC

Niles, Illinois, United States

Site Status

Onc/Hem Associates of Central Illinois

Peoria, Illinois, United States

Site Status

Hematology Oncology Associates of Illinois

Skokie, Illinois, United States

Site Status

Central Indiana Cancer Centers

Indianapolis, Indiana, United States

Site Status

Iowa Cancer Care, PLC

Cedar Rapids, Iowa, United States

Site Status

Iowa Oncology Associates

Cedar Rapids, Iowa, United States

Site Status

Central Maryland Oncology Center

Columbia, Maryland, United States

Site Status

Central Maryland Oncology Group

Towson, Maryland, United States

Site Status

Impath Predictive Oncology

Franklin, Massachusetts, United States

Site Status

Minnesota Oncology Hematology, PA

Minneapolis, Minnesota, United States

Site Status

Minnesota Oncology Hematology, PA

Saint Paul, Minnesota, United States

Site Status

Missouri Cancer Associates

Columbia, Missouri, United States

Site Status

Kansas City Oncology and Hematology Group

Kansas City, Missouri, United States

Site Status

The Center for Cancer Care & Research

St Louis, Missouri, United States

Site Status

Hematology Oncology Centers of the Northern Rockies

Billings, Montana, United States

Site Status

New Mexico Cancer Center Associates

Santa Fe, New Mexico, United States

Site Status

New York Oncology Hematology, PC

Albany, New York, United States

Site Status

New York Oncology Hematology

Albany, New York, United States

Site Status

HemOnCare, PC

Brooklyn, New York, United States

Site Status

North Shore Hematology/Oncology Associates, P.C.

East Setauket, New York, United States

Site Status

Cancer Research of Long Island

Great Neck, New York, United States

Site Status

Interlakes Oncology & Hematology, P.C.

Rochester, New York, United States

Site Status

Asheville Hematology & Oncology Associates, PA

Asheville, North Carolina, United States

Site Status

Raleigh Hematology Oncology Clini

Cary, North Carolina, United States

Site Status

Regional Hamatology Oncology Associates

Durham, North Carolina, United States

Site Status

Northeastern Carolina Hematology & Oncology, PA

Hickory, North Carolina, United States

Site Status

Raleigh Hematology Oncology Clinic

Raleigh, North Carolina, United States

Site Status

Raleigh Hematology Oncology Clinic

Raleigh, North Carolina, United States

Site Status

Piedmont Hematology Onccology Associates, P.A.

Winston-Salem, North Carolina, United States

Site Status

Dayton Oncology/Hematology, PA

Kettering, Ohio, United States

Site Status

Cancer Care Associates - Baptist Campus

Oklahoma City, Oklahoma, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Willamette Valley Cancer Center

Eugene, Oregon, United States

Site Status

Hematology & Oncolgy Assoc of NE PA

Dunmore, Pennsylvania, United States

Site Status

Medical Oncology Associates of Wymoning Valley, PC

Kingston, Pennsylvania, United States

Site Status

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Site Status

Temple Cancer Center

Philadelphia, Pennsylvania, United States

Site Status

Oncology-Hematology Associates

Pittsburgh, Pennsylvania, United States

Site Status

Cancer Centers of the Carolinas

Greenville, South Carolina, United States

Site Status

University of Tennessee Cancer Institute

Memphis, Tennessee, United States

Site Status

Texas Oncology, PA

Abilene, Texas, United States

Site Status

Texas Oncology, P.A

Arlington, Texas, United States

Site Status

South Austin Cancer Center

Austin, Texas, United States

Site Status

Mamie McFadden Ward Cancer Center

Beaumont, Texas, United States

Site Status

Texas Oncology, P.A.

Bedford, Texas, United States

Site Status

US Oncology Research

Dallas, Texas, United States

Site Status

Texas Cancer Center at Medical City

Dallas, Texas, United States

Site Status

Texas Onclology, PA

Dallas, Texas, United States

Site Status

The Texas Cancer Center - Dallas Southwest

Dallas, Texas, United States

Site Status

Texas Oncology, PA

Dallas, Texas, United States

Site Status

Texoma Cancer Center

Denison, Texas, United States

Site Status

Texas Cancer Center

Fort Worth, Texas, United States

Site Status

Texas Oncology, PA

Fort Worth, Texas, United States

Site Status

San Antonio Tumor and Blood Clinic

Fredicksburg, Texas, United States

Site Status

Texas Oncology, PA

Garland, Texas, United States

Site Status

Texas Oncology, PA

Houston, Texas, United States

Site Status

Texas Oncology, PA

Houston, Texas, United States

Site Status

Texas Oncology, PA

Houston, Texas, United States

Site Status

Texas Oncology, PA

Houston, Texas, United States

Site Status

Texas Oncology, PA

Irving, Texas, United States

Site Status

Lake Vista Cancer Center

Lewisville, Texas, United States

Site Status

Texas Cancer Center of Mesquite

Mesquite, Texas, United States

Site Status

Allison Cancer Center

Midland, Texas, United States

Site Status

West Texas Cancer Center

Odessa, Texas, United States

Site Status

an Antonio Tumor and Blood Clinic

San Antonio, Texas, United States

Site Status

Hematology Oncology Associates of South Texas

San Antonio, Texas, United States

Site Status

San Antonio, Texas, United States

Site Status

Tyler Cancer Center

Tyler, Texas, United States

Site Status

Waco Cancer Care & Research Center

Waco, Texas, United States

Site Status

Deke Slayton Cancer Center

Webster, Texas, United States

Site Status

Texoma Cancer Center

Wichita Falls, Texas, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Fairfax Northern Virginia Hematology-Oncology, PC

Fairfax, Virginia, United States

Site Status

Virginia Oncology Associates

Newport News, Virginia, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

Site Status

Oncology & Hematology Associates of South West Virginia, Inc.

Salem, Virginia, United States

Site Status

Puget Sound Cancer Centers

Edmonds, Washington, United States

Site Status

Ranier Oncology Professional Services

Puyallup, Washington, United States

Site Status

Washington Cancer Center, P.C.Puget Sound Cancer Cente

Seattle, Washington, United States

Site Status

Cancer Care Northwest

Spokane, Washington, United States

Site Status

MultiCare Health System

Tacoma, Washington, United States

Site Status

Northwest Cancer Specialists, PC

Vancouver, Washington, United States

Site Status

University of Wisconsin Comprehensive Cancer Center

Madison, Wisconsin, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

028

Identifier Type: -

Identifier Source: org_study_id

NCT00021411

Identifier Type: -

Identifier Source: nct_alias

NCT00036322

Identifier Type: -

Identifier Source: nct_alias