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

October 18, 2011 updated by: Astellas Pharma Inc

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

600

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Collaborators

OSI Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2001

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

June 15, 2004

First Submitted That Met QC Criteria

June 16, 2004

First Posted (Estimate)

June 17, 2004

Study Record Updates

Last Update Posted (Estimate)

October 20, 2011

Last Update Submitted That Met QC Criteria

October 18, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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