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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 CenterIndianapolis, Indiana  46202-5265
Memorial Hospital of South BendSouth Bend, Indiana  46601
Midwestern Regional Medical CenterZion, Illinois  60099
Texas Oncology, P.A.Dallas, Texas  75246
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Franklin Square Hospital CenterBaltimore, Maryland  21237
Cooper Cancer InstituteCamden, New Jersey  08103
Southern California Permanente Medical GroupDowney, California  90242
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Carolinas Hematology-Oncology AssociatesCharlotte, North Carolina  28203
Montefiore Medical CenterBronx, New York  10467-2490
Hematology Oncology Associates of the Quad CitiesBettendorf, Iowa  52722
Arlington Cancer CenterArlington, Texas  76012
Duluth ClinicDuluth, Minnesota  55805
Cancer Centers of the CarolinasGreenville, South Carolina  29605
Wilshire Oncology Medical Group, Inc.Rancho Cucamonga, California  91730
Elkhart General HospitalElkhart, Indiana  46515
Florida Cancer SpecialistsFort Myers, Florida  33901
Galesburg Cottage HospitalGalesburg, Illinois  61401
Deerpath Medical AssociatesLake Forest, Illinois  60045
North Shore Oncology Hematology AssociatesLibertyville, Illinois  60048
Midwest Cancer Research Group, Inc.Skokie, Illinois  60077
Missouri Cancer AssociatesColumbia, Missouri  65201
Cancer Care CenterNew Albany, Indiana  47150
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Morton Plant HospitalClearwater, Florida  33756
Lakeland Regional Medical CenterLakeland, Florida  33804
Sharp Memorial HospitalSan Diego, California  92123
Highlands Oncology GroupSpringdale, Arkansas  72764
Center for Cancer Care at Goshen Health SystemGoshen, Indiana  46526
Florida Oncology AssociatesOrange Park, Florida  32073
LaPorte HospitalLaPorte, Indiana  46350-0250
Saint Joseph's Regional Medical CenterSouth Bend, Indiana  46634-1935
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
Regional Hematology Oncology AssociatesDurham, North Carolina  27704
Cancer Care AssociatesTulsa, Oklahoma  74136
Nebraska Methodist HospitalOmaha, Nebraska  68114
Central Jersey Oncology CenterNew Brunswick, New Jersey  08901
New York Oncology Hematology, P.C.Albany, New York  12208
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
East Tennessee Oncology/Hematology, P.C.Knoxville, Tennessee  37920
Lakeland Regional Cancer CenterLakeland, Florida  33805
Broward Oncology AssociatesFt. Lauderdale, Florida  33308
Baptist Hospital of East TennesseeKnoxville, Tennessee  37920
Northwest Medical Specialties, PLLCTacoma, Washington  98405
The Sarah Cannon Cancer CenterNashville, Tennessee  37203
Providence Holy Cross Medical CenterMission Hills, California  91345
Medical Consultants, PCMuncie, Indiana  47304
Northwest Medical Specialists, PLLCTacoma, Washington  98405
Medical Center of VincennesVincennes, Indiana  47591
Clinical Trials & Research Associates, Inc.Montebello, California  90640
Bay Area Cancer Research GroupConcord, California  94520
Georgetown University HospitalWashington, District of Columbia  20007
Annapolis Oncology CenterAnnapolis, Maryland  21401
Kansas City Cancer CenterKansas City, Missouri  64111
Mid Ohio Oncology/Hematology, Inc.Columbus, Ohio  43213
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Marilyn Norton, M. D.Chula Vista, California  91911
Sharp Rees-StealyLa Mesa, California  91942
Grossmont HospitalLa Mesa, California  91942
N. County Oncology MedicalOceanside, California  92056
Florida HospitalOrlando, Florida  32803
Florida Hospital Memorial Division, Cancer Care CenterOrmond Beach, Florida  32174
Hematology Oncology Associates of Illinois (HOAI)Chicago, Illinois  60657
Swedish Covenant Cancer CenterChicago, Illinois  60625
Cancer Care Specialists of Central ILDecatur, Illinois  62526
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
Center for Cancer and Blood DisordersBethesda, Maryland  20817
Memorial HospitalChattanooga, Tennessee  37404
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLCGallatin, Tennessee  37066
Southwest Fort Worth Cancer CenterFort Worth, Texas  76132
Medical Consultants, Ltd.Milwaukee, Wisconsin  53215
Kaiser Permanente Northwest RegionPortland, Oregon  97227
Palo Verde Hematology OncologyGlendale, Arizona  85304
Hematology/Oncology Associates of the Treasure CoastPort St. Lucie, Florida  34952
Raleigh Hematology Oncology AssociationRaleigh, North Carolina  27609
Gaston Hematology & Oncology AssociatesGastonia, North Carolina  28054
Wishard HospitalIndianapolis, Indiana  46202
Lakeland HospitalSt. Joseph, Michigan  49085
Freeman Health SystemJoplin, Missouri  64804
Missouri Baptist Medical CenterSaint Louis, Missouri  63131
UAB CCC Clinical Studies UnitBirmingham, Alabama  35233-2115
Department of Veterans Affairs Medical CenterBirmingham, Alabama  35233
Little Rock Hematology Oncology BentonBenton, Arkansas  72015
Heritage Physician Group, OncologyHot Springs, Arkansas  71913
East Bay Medical Oncology/Hematology Medical Associates, Inc.Antioch, California  94509
East Valley Hematology Oncology Medical GroupBurbank, California  91505
Rosalba Rodriquez, M. D.Chula Vista, California  91911
North Valley Hematology Oncology GroupMission Hills, California  91345
Oncology Care Medical Associates, Inc.Montebello, California  90640
Beverly Oncology & ImagingMontebello, California  90640
Beverly Oncology and Imaging Center, Inc.Montebello, California  90640
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Medical Oncology Associates - SDSan Diego, California  92123
East Bay Medical Oncology/Hematology Medcial Associates, Inc.San leandro, California  94578
Santa Monica Hematology/OncologySanta 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/HematologyNew Milford, Connecticut  06776
New Milford HospitalNew Milford, Connecticut  06776
Sharon HospitalSharon, Connecticut  06069
Charlotte Hungerford HospitalTorrington, Connecticut  06790
Washington Hospital Center - Washington Cancer InstituteWashington, District of Columbia  20010
Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PAAltamonte Springs, Florida  32701
The Center for Hematology/OncologyBoca Raton, Florida  33486
Joseph DeFeliceClearwater, Florida  33756
Oncology PhysiciansClearwater, Florida  33761
Hitesh PatelClearwater, Florida  33756
Space Coast Medical AssociatesCocoa Beach, Florida  32931
Florida Cancer SpeicalistsFort Myers, Florida  33901
South Florida Oncology HematologyHollywood, Florida  33021
University of Florida/Jacksonville Faculty ClinicJacksonville, Florida  32209
Shands JacksonvilleJacksonville, Florida  32209
Mohammad Kamal, M. D.Ocala, Florida  34471
Ocala Research Institute, Inc.Ocala, Florida  34480
Hematology & Oncology Consultants, PAOrlando, Florida  32804
Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PAOrlando, Florida  32804
Peachtree Hematology & Oncology Consultants, P. C.Atlanta, Georgia  30309
Straub Clinic & HospitalHonolulu, Hawaii  96813
Kapiolani Medical Center for Women & ChildrenHonolulu, Hawaii  96826
Decatur Memorial Hospital/Clinical ResearchDecatur, Illinois  62526
St. Mary Medical CenterGalesburg, Illinois  61401
Medical & Surgical Specialists, LLCGalesburg, Illinois  61401
North Shore Cancer Research AssociationSkokie, Illinois  60076
Indiana University-Clarian Health PartnersIndianapolis, Indiana  46202
Veterans AdministrationIndianapolis, Indiana  46202
Ball Cancer Center at Forest Ridge Medical PavilionNew Castle, Indiana  47362
TricareVincennes, Indiana  47591
Genesis Health SystemDavenport, Iowa  52803
Kansas City Cancer CenterKansas City, Kansas  66112
Auerbach Hematology Oncology AssociatesBaltimore, Maryland  21237
Associates in Oncology/Hematology, P.C.Kensington, Maryland  20895
Department of Hematology/OncologyWorcester, Massachusetts  01608
Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.DWorcester, Massachusetts  01608
Fallon Clinic Pharmacy-Linda Tolf, R.Ph.Worcester, Massachusetts  01608
St. Joseph Mercy Hospital, Cancer Center, OC 139Ann Arbor, Michigan  48106
Sparrow Health SystemLansing, Michigan  48912
Ellis Fischel Cancer Center - University of Missouri Health CareColumbia, Missouri  65203
Boone Hospital CenterColumbia, Missouri  65201
Freeman Cancer InstituteJoplin, Missouri  64804
Horizons West Medical GroupScottsbluff, Nebraska  69361
Nevada Cancer CentersLas Vegas, Nevada  89109
University HospitalNewark, 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 DriveArmonk, New York  10504
Albert Einstein Cancer Center at the Montefiore Medical ParkBronx, New York  10461
The Jack D. Weiler Hospital of the Albert Einstein College of MedicineBronx, New York  10461
North Shore Hematology Oncology Associates, P.C.East Setauket, New York  11733
Queens Medical AssociatesFresh Meadows, New York  11365
Myrna Sanchez, MDMalone, New York  12953
Alice Hyde Medical CenterMalone, New York  12953
Raleigh Hematology Oncology AssociatesCary, North Carolina  27511
Carolinas HealthCare System/Carolinas Medical CenterCharlotte, North Carolina  28203
Regional Hematology Oncology AssociationDurham, North Carolina  27704
Piedmont Hematology Oncology AssociatesWinston Salem, North Carolina  27103
Cancer Treatment & Research CenterBismarck, North Dakota  58501
Odyssey ResearchBismarck, North Dakota  58501
Case Western Reserve University- University Hospitals of ClevelandCleveland, Ohio  44106
Mid Ohio Oncology/HematologyColumbus, Ohio  43222
Community Health Partners, Ireland Cancer CenterElyria, Ohio  44035
UHHS Chagrin Highlands - Ireland Cancer CenterOrange Village, Ohio  44122
UHHS Westlake - Ireland Cancer CenterWestlake, Ohio  44145
Vita Hematology Oncology, P.C.Bethlehem, Pennsylvania  18015
Greater Philadelphia Cancer and Hematology Specialists, PCPhiladelphia, Pennsylvania  19114
Robert Packer HospitalSayre, Pennsylvania  18840
Guthrie ClinicSayre, 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 GroupKnoxville, Tennessee  37932
Baptist Hospital WestKnoxville, Tennessee  37922
Cumberland Oncology & HematologyOak Ridge, Tennessee  37830
Center for Oncology Research and Treatment, PADallas, Texas  75230
Dallas Oncology Consultants, PADallas, Texas  75237
Texas Cancer Associates, LLPDallas, Texas  75231
The University of Texas - M. D. Anderson Cancer CenterHouston, Texas  77030
Shore Cancer CenterNassawadox, Virginia  23413
VLCC-ElkhornElkhorn, Wisconsin  53121
Aurora Health Center-SlingerSlinger, Wisconsin  53086
VLCC-West BendWest Bend, Wisconsin  53095