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Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3
18 Years
Not Enrolling
Non Small Cell Lung Carcinoma

Thank you

Trial Information

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Gefitinib (Iressa) as Third-Line Therapy in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Inclusion Criteria:

- Clinical diagnosis of non-small cell lung cancer

- Non-small cell lung cancer that is not curable with surgery, radiation, or combined
modality chemoradiation

- Failed two prior chemotherapy regimens which must have included platinum

- Measurable disease

Exclusion Criteria:

- Treatment with more than two prior chemotherapy regimens

- History of bone marrow transplantation or stem cell support

- Pregnant or lactating women

- Known history of prior gefitinib therapy

- Known history of prior TLK286 therapy

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


United States: Food and Drug Administration

Study ID:




Start Date:

Completion Date:

May 2005

Related Keywords:

  • Non Small Cell Lung Carcinoma
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Indiana University Cancer Center Indianapolis, Indiana  46202-5265
Memorial Hospital of South Bend South Bend, Indiana  46601
Midwestern Regional Medical Center Zion, Illinois  60099
Texas Oncology, P.A. Dallas, Texas  75246
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Franklin Square Hospital Center Baltimore, Maryland  21237
Cooper Cancer Institute Camden, New Jersey  08103
Southern California Permanente Medical Group Downey, California  90242
Dakota Cancer Institute Fargo, North Dakota  58103-4940
Carolinas Hematology-Oncology Associates Charlotte, North Carolina  28203
Montefiore Medical Center Bronx, New York  10467-2490
Hematology Oncology Associates of the Quad Cities Bettendorf, Iowa  52722
Arlington Cancer Center Arlington, Texas  76012
Duluth Clinic Duluth, Minnesota  55805
Cancer Centers of the Carolinas Greenville, South Carolina  29605
Wilshire Oncology Medical Group, Inc. Rancho Cucamonga, California  91730
Elkhart General Hospital Elkhart, Indiana  46515
Florida Cancer Specialists Fort Myers, Florida  33901
Galesburg Cottage Hospital Galesburg, Illinois  61401
Deerpath Medical Associates Lake Forest, Illinois  60045
North Shore Oncology Hematology Associates Libertyville, Illinois  60048
Midwest Cancer Research Group, Inc. Skokie, Illinois  60077
Missouri Cancer Associates Columbia, Missouri  65201
Cancer Care Center New Albany, Indiana  47150
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Morton Plant Hospital Clearwater, Florida  33756
Lakeland Regional Medical Center Lakeland, Florida  33804
Sharp Memorial Hospital San Diego, California  92123
Highlands Oncology Group Springdale, Arkansas  72764
Center for Cancer Care at Goshen Health System Goshen, Indiana  46526
Florida Oncology Associates Orange Park, Florida  32073
LaPorte Hospital LaPorte, Indiana  46350-0250
Saint Joseph's Regional Medical Center South Bend, Indiana  46634-1935
University of Alabama at Birmingham Birmingham, Alabama  35294-3300
Regional Hematology Oncology Associates Durham, North Carolina  27704
Cancer Care Associates Tulsa, Oklahoma  74136
Nebraska Methodist Hospital Omaha, Nebraska  68114
Central Jersey Oncology Center New Brunswick, New Jersey  08901
New York Oncology Hematology, P.C. Albany, New York  12208
Hospital of the University of Pennsylvania Philadelphia, Pennsylvania  19104
East Tennessee Oncology/Hematology, P.C. Knoxville, Tennessee  37920
Lakeland Regional Cancer Center Lakeland, Florida  33805
Broward Oncology Associates Ft. Lauderdale, Florida  33308
Baptist Hospital of East Tennessee Knoxville, Tennessee  37920
Northwest Medical Specialties, PLLC Tacoma, Washington  98405
The Sarah Cannon Cancer Center Nashville, Tennessee  37203
Providence Holy Cross Medical Center Mission Hills, California  91345
Medical Consultants, PC Muncie, Indiana  47304
Northwest Medical Specialists, PLLC Tacoma, Washington  98405
Medical Center of Vincennes Vincennes, Indiana  47591
Clinical Trials & Research Associates, Inc. Montebello, California  90640
Bay Area Cancer Research Group Concord, California  94520
Georgetown University Hospital Washington, District of Columbia  20007
Annapolis Oncology Center Annapolis, Maryland  21401
Kansas City Cancer Center Kansas City, Missouri  64111
Mid Ohio Oncology/Hematology, Inc. Columbus, Ohio  43213
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Marilyn Norton, M. D. Chula Vista, California  91911
Sharp Rees-Stealy La Mesa, California  91942
Grossmont Hospital La Mesa, California  91942
N. County Oncology Medical Oceanside, California  92056
Florida Hospital Orlando, Florida  32803
Florida Hospital Memorial Division, Cancer Care Center Ormond Beach, Florida  32174
Hematology Oncology Associates of Illinois (HOAI) Chicago, Illinois  60657
Swedish Covenant Cancer Center Chicago, Illinois  60625
Cancer Care Specialists of Central IL Decatur, Illinois  62526
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Memorial Hospital Chattanooga, Tennessee  37404
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Gallatin, Tennessee  37066
Southwest Fort Worth Cancer Center Fort Worth, Texas  76132
Medical Consultants, Ltd. Milwaukee, Wisconsin  53215
Kaiser Permanente Northwest Region Portland, Oregon  97227
Palo Verde Hematology Oncology Glendale, Arizona  85304
Hematology/Oncology Associates of the Treasure Coast Port St. Lucie, Florida  34952
Raleigh Hematology Oncology Association Raleigh, North Carolina  27609
Gaston Hematology & Oncology Associates Gastonia, North Carolina  28054
Wishard Hospital Indianapolis, Indiana  46202
Lakeland Hospital St. Joseph, Michigan  49085
Freeman Health System Joplin, Missouri  64804
Missouri Baptist Medical Center Saint Louis, Missouri  63131
UAB CCC Clinical Studies Unit Birmingham, Alabama  35233-2115
Department of Veterans Affairs Medical Center Birmingham, Alabama  35233
Little Rock Hematology Oncology Benton Benton, Arkansas  72015
Heritage Physician Group, Oncology Hot Springs, Arkansas  71913
East Bay Medical Oncology/Hematology Medical Associates, Inc. Antioch, California  94509
East Valley Hematology Oncology Medical Group Burbank, California  91505
Rosalba Rodriquez, M. D. Chula Vista, California  91911
North Valley Hematology Oncology Group Mission Hills, California  91345
Oncology Care Medical Associates, Inc. Montebello, California  90640
Beverly Oncology & Imaging Montebello, California  90640
Beverly Oncology and Imaging Center, Inc. Montebello, California  90640
Clinical Trials and Research Associates, Inc. Montebello, California  60460
Medical Oncology Associates - SD San Diego, California  92123
East Bay Medical Oncology/Hematology Medcial Associates, Inc. San leandro, California  94578
Santa Monica Hematology/Oncology Santa Monica, California  90404
Diablo Valley Oncology & Hematology Medical Group, Inc. Walnut Creek, California  94598
Medical Oncology & Hematology, P. C. Hamden, Connecticut  06518
Medical Oncology & Hematology, P.C. Meriden, Connecticut  06451
Northwestern Connecticut Oncology/Hematology New Milford, Connecticut  06776
New Milford Hospital New Milford, Connecticut  06776
Sharon Hospital Sharon, Connecticut  06069
Charlotte Hungerford Hospital Torrington, Connecticut  06790
Washington Hospital Center - Washington Cancer Institute Washington, District of Columbia  20010
Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PA Altamonte Springs, Florida  32701
The Center for Hematology/Oncology Boca Raton, Florida  33486
Joseph DeFelice Clearwater, Florida  33756
Oncology Physicians Clearwater, Florida  33761
Hitesh Patel Clearwater, Florida  33756
Space Coast Medical Associates Cocoa Beach, Florida  32931
Florida Cancer Speicalists Fort Myers, Florida  33901
South Florida Oncology Hematology Hollywood, Florida  33021
University of Florida/Jacksonville Faculty Clinic Jacksonville, Florida  32209
Shands Jacksonville Jacksonville, Florida  32209
Mohammad Kamal, M. D. Ocala, Florida  34471
Ocala Research Institute, Inc. Ocala, Florida  34480
Hematology & Oncology Consultants, PA Orlando, Florida  32804
Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PA Orlando, Florida  32804
Peachtree Hematology & Oncology Consultants, P. C. Atlanta, Georgia  30309
Straub Clinic & Hospital Honolulu, Hawaii  96813
Kapiolani Medical Center for Women & Children Honolulu, Hawaii  96826
Decatur Memorial Hospital/Clinical Research Decatur, Illinois  62526
St. Mary Medical Center Galesburg, Illinois  61401
Medical & Surgical Specialists, LLC Galesburg, Illinois  61401
North Shore Cancer Research Association Skokie, Illinois  60076
Indiana University-Clarian Health Partners Indianapolis, Indiana  46202
Veterans Administration Indianapolis, Indiana  46202
Ball Cancer Center at Forest Ridge Medical Pavilion New Castle, Indiana  47362
Tricare Vincennes, Indiana  47591
Genesis Health System Davenport, Iowa  52803
Kansas City Cancer Center Kansas City, Kansas  66112
Auerbach Hematology Oncology Associates Baltimore, Maryland  21237
Associates in Oncology/Hematology, P.C. Kensington, Maryland  20895
Department of Hematology/Oncology Worcester, Massachusetts  01608
Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.D Worcester, Massachusetts  01608
Fallon Clinic Pharmacy-Linda Tolf, R.Ph. Worcester, Massachusetts  01608
St. Joseph Mercy Hospital, Cancer Center, OC 139 Ann Arbor, Michigan  48106
Sparrow Health System Lansing, Michigan  48912
Ellis Fischel Cancer Center - University of Missouri Health Care Columbia, Missouri  65203
Boone Hospital Center Columbia, Missouri  65201
Freeman Cancer Institute Joplin, Missouri  64804
Horizons West Medical Group Scottsbluff, Nebraska  69361
Nevada Cancer Centers Las Vegas, Nevada  89109
University Hospital Newark, New Jersey  07103
New Mexico Oncology Hematology Consultants, Ltd. Albuquerque, New Mexico  87109
New York Oncology Hematology, P. C. Albany, New York  12208
Business Park Drive Armonk, New York  10504
Albert Einstein Cancer Center at the Montefiore Medical Park Bronx, New York  10461
The Jack D. Weiler Hospital of the Albert Einstein College of Medicine Bronx, New York  10461
North Shore Hematology Oncology Associates, P.C. East Setauket, New York  11733
Queens Medical Associates Fresh Meadows, New York  11365
Myrna Sanchez, MD Malone, New York  12953
Alice Hyde Medical Center Malone, New York  12953
Raleigh Hematology Oncology Associates Cary, North Carolina  27511
Carolinas HealthCare System/Carolinas Medical Center Charlotte, North Carolina  28203
Regional Hematology Oncology Association Durham, North Carolina  27704
Piedmont Hematology Oncology Associates Winston Salem, North Carolina  27103
Cancer Treatment & Research Center Bismarck, North Dakota  58501
Odyssey Research Bismarck, North Dakota  58501
Case Western Reserve University- University Hospitals of Cleveland Cleveland, Ohio  44106
Mid Ohio Oncology/Hematology Columbus, Ohio  43222
Community Health Partners, Ireland Cancer Center Elyria, Ohio  44035
UHHS Chagrin Highlands - Ireland Cancer Center Orange Village, Ohio  44122
UHHS Westlake - Ireland Cancer Center Westlake, Ohio  44145
Vita Hematology Oncology, P.C. Bethlehem, Pennsylvania  18015
Greater Philadelphia Cancer and Hematology Specialists, PC Philadelphia, Pennsylvania  19114
Robert Packer Hospital Sayre, Pennsylvania  18840
Guthrie Clinic Sayre, Pennsylvania  18840
Medical University of S.C. Charleston, South Carolina  29425
Chattanooga Oncology & Hemtology Associates, P. C. Chattanooga, Tennessee  37404
The Consultant Group, P.C. Franklin, Tennessee  37067
Thompson Oncology Group Knoxville, Tennessee  37932
Baptist Hospital West Knoxville, Tennessee  37922
Cumberland Oncology & Hematology Oak Ridge, Tennessee  37830
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Dallas Oncology Consultants, PA Dallas, Texas  75237
Texas Cancer Associates, LLP Dallas, Texas  75231
The University of Texas - M. D. Anderson Cancer Center Houston, Texas  77030
Shore Cancer Center Nassawadox, Virginia  23413
VLCC-Elkhorn Elkhorn, Wisconsin  53121
Aurora Health Center-Slinger Slinger, Wisconsin  53086
VLCC-West Bend West Bend, Wisconsin  53095