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

Information source: OSI Pharmaceuticals
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Non-Small Cell Lung Cancer

Intervention: Exisulind (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: OSI Pharmaceuticals

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.

Clinical Details

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Exclusion Criteria:

Locations and Contacts

Birmingham Hematology Oncology Associates, Birmingham, Alabama 35205, United States

Birmingham Hematology and Oncology Associates, LLC, Birmingham, Alabama 35235, United States

Arizona Clinical Research Center, Tucson, Arizona 85715, 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

Arkansas Oncology Associates, PA, Little Rock, Arkansas 72207, United States

Pacific Coast Hematology/Oncology Medical Group, Inc., Fountain Valley, California 92708, United States

Sharp Clinical Oncology Research, San Diego, California 92123, United States

California Cancer Care, Inc., Greenbrae, California 94904, United States

Scripps Cancer Center, SanDiego, California 92121, United States

Redwood Regional Medical Group, Santa Rosa, California 95403, United States

RMCC, Denver, Colorado 80218, United States

Rocky Mountain Cancer Centers, Fort Collins, Colorado 80524, United States

Rocky Mountain Cancer Center, Boulder, Colorado 80304, United States

Rocky Mountain Cancer Centers, Colorado Springs, Colorado 80909, United States

Rocky Mountain Cancer Centers, Englewood, Colorado 80110, United States

Rocky Mountain Cancer Centers, Littleton, Colorado 80120, United States

Rocky Mountain Cancer Centers, Thornton, Colorado 80260, United States

12. Rocky Mountain Cancer Centers-Englewood, Englewood, Colorado 80110, United States

Ocala Oncology Center, Ocala, Florida 34474, United States

Comprehensive Cancer Care Specialists at Boca Raton, Boca Raton, Florida 33428, United States

Florida Oncology Associates, Jacksonville, Florida 32207, United States

Florida Oncology Associates, Orange Park, Florida 32073, United States

Boca Raton Comprehensive Cancer Center, Boca Raton, Florida 33428, United States

South Florida Oncology & Hematology Consultants, Lauderhill, Florida 33319, United States

Cancer Centers of Florida, Orlando, Florida 32806, United States

Lauderhill Lakes, Plantation, Florida 33324, United States

Florida Cancer Institute, New Port Richey, Florida 34655, United States

North Florida Hematology & Oncology Association, Jacksonville, Florida 32204, United States

Onc/Hem Associates of Central Illinois, Peoria, Illinois 61602, United States

Evanston Northwestern Healthcare, Evanston, Illinois 60201, United States

Hematology Oncology Associates of Illinois, Skokie, Illinois 60077, United States

Northwest Medical Specialists, PC, Niles, Illinois 60714, 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 Group, Towson, Maryland 21204, United States

Central Maryland Oncology Center, Columbia, Maryland 21044, United States

Impath Predictive Oncology, Franklin, Massachusetts 02038, United States

Minnesota Oncology Hematology, PA, St. Paul, Minnesota 55102, United States

Minnesota Oncology Hematology, PA, Minneapolis, Minnesota 55404, United States

The Center for Cancer Care & Research, St. Louis, Missouri 63141, United States

Kansas City Oncology and Hematology Group, Kansas City, Missouri 64111, United States

Missouri Cancer Associates, Columbia, Missouri 65201, 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

HemOnCare, PC, Brooklyn, New York 11235, United States

Cancer Research of Long Island, Great Neck, New York 11023, United States

North Shore Hematology/Oncology Associates, P.C., East Setauket, New York 11733, United States

Interlakes Oncology & Hematology, P.C., Rochester, New York 14623, United States

New York Oncology Hematology, Albany, New York 12208, United States

New York Oncology Hematology, PC, Albany, New York 12208, United States

Northeastern Carolina Hematology & Oncology, PA, Hickory, North Carolina 28602, United States

Asheville Hematology & Oncology Associates, PA, Asheville, North Carolina 28801, United States

Piedmont Hematology Onccology Associates, P.A., Winston-Salem, North Carolina 27103, United States

Raleigh Hematology Oncology Clini, Cary, North Carolina 27511, United States

Raleigh Hematology Oncology Clinic, Raleigh, North Carolina 27609, United States

Regional Hamatology Oncology Associates, Durham, North Carolina 27704, United States

Raleigh Hematology Oncology Clinic, Raleigh, North Carolina 27607, 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

Temple Cancer Center, Philadelphia, Pennsylvania 19140, United States

Thomas Jefferson University Hospital, Philadelphia, Pennsylvania 19107, 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

US Oncology Research, Dallas, Texas 75204, United States

Tyler Cancer Center, Tyler, Texas 75702, United States

The Texas Cancer Center - Dallas Southwest, Dallas, Texas 75237, United States

Texas Oncology, P.A, Arlington, Texas 76012, United States

Waco Cancer Care & Research Center, Waco, Texas 76712, United States

Texas Oncology, P.A., Bedford, Texas 76022, United States

Texas Cancer Center of Mesquite, Mesquite, Texas 75150, United States

Texas Oncology, PA, Irving, Texas 75061, United States

Texas Oncology, PA, Houston, Texas 77030, United States

Texoma Cancer Center, Denison, Texas 75020-2088, United States

San Antonio Tumor and Blood Clinic, Fredicksburg, Texas 78624, United States

Mamie McFadden Ward Cancer Center, Beaumont, Texas 77702-1449, United States

Texas Oncology, PA, Abilene, Texas 79601-2301, United States

Texas Oncology, PA, Houston, Texas 77029, United States

Texas Cancer Center, Ft. Worth, Texas 76104, United States

Hematology Oncology Associates of South Texas, San Antonio, Texas 78229, United States

Deke Slayton Cancer Center, Webster, Texas 77589, United States

Texas Onclology, PA, Dallas, Texas 75231, United States

Texas Oncology, PA, Houston, Texas 77024, United States

West Texas Cancer Center, Odessa, Texas 79761, United States

Texas Oncology, PA, Garland, Texas 75042-5788, United States

Lake Vista Cancer Center, Lewisville, Texas 75067, United States

Texas Oncology, PA, Dallas, Texas 75246, United States

Texas Oncology, PA, Fort Worth, Texas 76104, United States

South Austin Cancer Center, Austin, Texas 78745, United States

Texas Cancer Center at Medical City, Dallas, Texas 75230-2510, United States

Texoma Cancer Center, Wichita Falls, Texas 76310, United States

Allison Cancer Center, Midland, Texas 79701-5946, United States

Texas Oncology, PA, Houston, Texas 77074-1811, United States

San Antonio Tumor and Blood Clinic, San Antonio, Texas 78217, United States

San Antonio, Texas, United States

Utah Cancer Specialists, Salt Lake City, Utah 84106, United States

Virginia Oncology Associates, Norfolk, Virginia 23502, United States

Oncology & Hematology Associates of South West Virginia, Inc., Salem, Virginia 24153, United States

Fairfax Northern Virginia Hematology-Oncology, PC, Fairfax, Virginia 22031, United States

Virginia Oncology Associates, Newport News, Virginia 23606, United States

Ranier Oncology Professional Services, Puyallup, Washington 98372, United States

MultiCare Health System, Tacoma, Washington 98405, United States

Puget Sound Cancer Centers, Edmonds, Washington 98026, United States

Cancer Care Northwest, Spokane, Washington 99218, United States

Washington Cancer Center, P.C. Puget Sound Cancer Cente, Seattle, Washington 98133, United States

Northwest Cancer Specialists, PC, Vancouver, Washington 98684, United States

University of Wisconsin Comprehensive Cancer Center, Madison, Wisconsin 53792, United States

Additional Information

OSI Website

Starting date: April 2001
Ending date: December 2004
Last updated: October 10, 2006

Page last updated: June 20, 2008

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