MedPath

Study of TLK286 (Telcyta) vs. Gefitinib in Locally Advanced or Metastatic Non-Small Cell Lung Cancer

Phase 3
Completed
Conditions
Non Small Cell Lung Carcinoma
Registration Number
NCT00080340
Lead Sponsor
Telik
Brief Summary

The purpose of this study is to determine if TLK286(Telcyta) is more effective than gefitinib (Iressa) in the treatment of non-small cell lung cancer.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
520
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (249)

Clinical Trials & Research Associates, Inc.

🇺🇸

Montebello, California, United States

Wilshire Oncology Medical Group, Inc.

🇺🇸

West Covina, California, United States

Medical Oncology & Hematology, P.C.

🇺🇸

Waterbury, Connecticut, United States

Joseph DeFelice

🇺🇸

Clearwater, Florida, United States

South Florida Oncology Hematology

🇺🇸

Hollywood, Florida, United States

Mohammad Kamal, M. D.

🇺🇸

Ocala, Florida, United States

Marilyn Norton, M. D.

🇺🇸

Chula Vista, California, United States

Grossmont Hospital

🇺🇸

La Mesa, California, United States

East Valley Hematology Oncology Medical Group

🇺🇸

Burbank, California, United States

Hitesh Patel

🇺🇸

Clearwater, Florida, United States

Florida Cancer Specialists

🇺🇸

Venice, Florida, United States

Providence Saint Joseph Medical Center

🇺🇸

Burbank, California, United States

Florida Cancer Speicalists

🇺🇸

Fort Myers, Florida, United States

Auerbach Hematology Oncology Associates

🇺🇸

Baltimore, Maryland, United States

Space Coast Medical Associates

🇺🇸

Merritt Island, Florida, United States

Broward Oncology Associates

🇺🇸

Ft. Lauderdale, Florida, United States

Boone Hospital Center

🇺🇸

Columbia, Missouri, United States

Ellis Fischel Cancer Center - University of Missouri Health Care

🇺🇸

Columbia, Missouri, United States

Florida Oncology Associates

🇺🇸

St. Augustine, Florida, United States

Decatur Memorial Hospital/Clinical Research

🇺🇸

Decatur, Illinois, United States

Ocala Research Institute, Inc.

🇺🇸

Ocala, Florida, United States

Tricare

🇺🇸

Vincennes, Indiana, United States

Hematology/Oncology Associates of The Treasure Coast

🇺🇸

Port St. Lucie, Florida, United States

Community Health Partners, Ireland Cancer Center

🇺🇸

Elyria, Ohio, United States

Franklin Square Hospital Center

🇺🇸

Baltimore, Maryland, United States

Freeman Cancer Institute

🇺🇸

Joplin, Missouri, United States

Alice Hyde Medical Center

🇺🇸

Malone, New York, United States

New York Oncology Hematology, P. C.

🇺🇸

Albany, New York, United States

Midwestern Regional Medical Center

🇺🇸

Zion, Illinois, United States

Medical Consultants, PC

🇺🇸

Muncie, Indiana, United States

Hematology Oncology Associates of Illinois (HOAI)

🇺🇸

Skokie, Illinois, United States

Department of Hematology/Oncology

🇺🇸

Worcester, Massachusetts, United States

Case Western Reserve University- University Hospitals of Cleveland

🇺🇸

Cleveland, Ohio, United States

Business Park Drive

🇺🇸

Armonk, New York, United States

Gaston Hematology & Oncology Associates

🇺🇸

Gastonia, North Carolina, United States

Albury Base Hospital

🇦🇺

Albury, New South Wales, Australia

Mid Ohio Oncology/Hematology

🇺🇸

Columbus, Ohio, United States

Flinders Medical Centre

🇦🇺

Bedford Park, South Australia, Australia

Texas Oncology, P.A.

🇺🇸

Ft. Worth, Texas, United States

Myrna Sanchez, MD

🇺🇸

Malone, New York, United States

UHHS Chagrin Highlands - Ireland Cancer Center

🇺🇸

Orange Village, Ohio, United States

Bankstown Lidcombe Hospital - Department of Medical Oncology

🇦🇺

Bankstown, Australia

Queens Medical Associates

🇺🇸

Fresh Meadows, New York, United States

Greater Philadelphia Cancer and Hematology Specialists, PC

🇺🇸

Philadelphia, Pennsylvania, United States

Arlington Cancer Center

🇺🇸

Arlington, Texas, United States

Dallas Oncology Consultants, PA

🇺🇸

Dallas, Texas, United States

Raleigh Hematology Oncology Associates

🇺🇸

Raleigh, North Carolina, United States

Northwest Medical Specialties, PLLC

🇺🇸

Lakewood, Washington, United States

Royal Hobart Hospital

🇦🇺

Hobart, Australia

Department of Medical Oncology-Newcastle Mater Misericordiae Hospital

🇦🇺

Waratah, New South Wales, Australia

Hospital das Clinicas da UFPR

🇧🇷

Curitiba, PR, Brazil

Hospital Militar

🇨🇱

Santiago, Chile

Texas Cancer Associates, LLP

🇺🇸

Dallas, Texas, United States

Clinical Trials Centre - Wollongong Hospital

🇦🇺

Wollongong, Australia

Hospital das Clinicas - Universidade de Sao Paulo

🇧🇷

Sao Paulo, SP, Brazil

Associacao de Combate ao cancer de Goias - Hospital

🇧🇷

Goiania, GO, Brazil

IORC GmbH

🇩🇪

Hamburg, Germany

Murray Valley Private Hospital

🇦🇺

Wodonga, Victoria, Australia

Clinica Las Condes

🇨🇱

Santiago, Chile

Clinica Santa Maria

🇨🇱

Santiago, Chile

Hospital FACH

🇨🇱

Santiago, Chile

Askllepios Fachkliniken

🇩🇪

Robert-Koch-Allee 2, Gauting, Germany

Sir Charles Gairdner Hospital

🇦🇺

Nedlands, Australia

Conjunto Hospitalar de Sorocaba

🇧🇷

Sao Paulo, SP, Brazil

Instituto do Cancer Arnaldo Vieira de Carvalho

🇧🇷

Sao Paulo, SP, Brazil

Fundacao Pio XII - Hospital do Cancer de Barretos

🇧🇷

Sao Paulo, SP, Brazil

FundacionArturo Lopez Perez

🇨🇱

Santiago, Chile

Hospital Clinico Universidad de Chile

🇨🇱

Santiago, Chile

Ospedale "Carlo Poma" - Divisione di Oncologia Medica ed

🇮🇹

Via Albertoni, Mantova, Italy

Department of Medical Oncology

🇬🇧

West Smithfield, London, United Kingdom

Div. of cancer Medicine - Princess Alexandra Centre-Ninewells Hospital & Medical School

🇬🇧

Dundee, United Kingdom

Allgemeines Kraken Haus St. Georg Onkologie

🇩🇪

Hamburg, Germany

Indiana University-Clarian Health Partners

🇺🇸

Indianapolis, Indiana, United States

Veterans Administration

🇺🇸

Indianapolis, Indiana, United States

Wishard Hospital

🇺🇸

Indianapolis, Indiana, United States

Regional Hematology Oncology Associates

🇺🇸

Durham, North Carolina, United States

Sharp Rees-Stealy

🇺🇸

San Diego, California, United States

Southern California Permanente Medical Group

🇺🇸

San Diego, California, United States

Medical Oncology Associates - SD

🇺🇸

San Diego, California, United States

Sharp Memorial Hospital

🇺🇸

San Diego, California, United States

East Bay Medical Oncology/Hematology Medcial Associates, Inc.

🇺🇸

San leandro, California, United States

Odyssey Research

🇺🇸

Fargo, North Dakota, United States

Dakota Cancer Institute

🇺🇸

Fargo, North Dakota, United States

Ospedale Garibaldi di Nesima - Oncologia Medica

🇮🇹

Via Palermo, Catania, Italy

Azienda Ospedaliera di Parma - U.O. di Oncologia

🇮🇹

Parma, Italy

UAB CCC Clinical Studies Unit

🇺🇸

Birmingham, Alabama, United States

Department of Veterans Affairs Medical Center

🇺🇸

Birmingham, Alabama, United States

University of Alabama at Birmingham

🇺🇸

Birmingham, Alabama, United States

Center for Cancer and Blood Disorders

🇺🇸

Bethesda, Maryland, United States

Nebraska Methodist Hospital

🇺🇸

Omaha, Nebraska, United States

Medical Consultants, Ltd.

🇺🇸

Milwaukee, Wisconsin, United States

Hospital Vera Cruz

🇧🇷

Belo Horizonte, MG, Brazil

Pro Onco Centro de Tratamento Oncologico S/C Ltda.

🇧🇷

Curitiba, PR, Brazil

Instituto do Cancer do Ceara

🇧🇷

Fortaleza, CE, Brazil

Hospital Sao Lucas-PUCRS

🇧🇷

Porto Alegre, RS, Brazil

Santo Andre Diagnosticos e Tratamentos Ltda.

🇧🇷

Santo Andre, SP, Brazil

Santo Andre Diagnosticos e Tratamentos

🇧🇷

Santo Andre, SP, Brazil

Complexo Hospitalar Heliopolis

🇧🇷

Sao Paulo, SP, Brazil

Universidade Federal de Sao Paulo - UNIFESP/EPM

🇧🇷

Sao Paulo, SP, Brazil

Missouri Baptist Medical Center

🇺🇸

St. Louis, Missouri, United States

Royal North Shore Hospital-Medical Oncology Dept.

🇦🇺

St. Leonards, Australia

Shands Jacksonville

🇺🇸

Jacksonville, Florida, United States

Hematology & Oncology Consultants, PA

🇺🇸

Winter Park, Florida, United States

Lakeland Regional Medical Center

🇺🇸

Lakeland, Florida, United States

Midwest Cancer Research Group, Inc.

🇺🇸

Skokie, Illinois, United States

Florida Hospital Memorial Division, Cancer Care Center

🇺🇸

Ormond Beach, Florida, United States

Cancer Care Specialists of Central IL

🇺🇸

Effingham, Illinois, United States

Joliet Oncology-Hematology Associates, Ltd.

🇺🇸

Morris, Illinois, United States

Medical & Surgical Specialists, LLC

🇺🇸

Galesburg, Illinois, United States

North Shore Cancer Research Association

🇺🇸

Skokie, Illinois, United States

Center for Cancer CAre at Goshen Health System

🇺🇸

Goshen, Indiana, United States

Elkhart General Hospital

🇺🇸

Elkhart, Indiana, United States

Indiana University Cancer Center

🇺🇸

Indianapolis, Indiana, United States

LaPorte Hospital

🇺🇸

La Porte, Indiana, United States

Hematology Oncology Associates of the Quad Cities

🇺🇸

Bettendorf, Iowa, United States

Medical Center of Vincennes

🇺🇸

Vincennes, Indiana, United States

Memorial Hospital of South Bend

🇺🇸

South Bend, Indiana, United States

Ball Cancer Center at Forest Ridge Medical Pavilion

🇺🇸

New Castle, Indiana, United States

Genesis Health System

🇺🇸

Davenport, Iowa, United States

New Mexico Oncology Hematology Consultants, Ltd.

🇺🇸

Albuquerque, New Mexico, United States

Raleigh Hematology Oncology Association

🇺🇸

Raleigh, North Carolina, United States

Regional Hematology Oncology Association

🇺🇸

Durham, North Carolina, United States

Mid Ohio Oncology/Hematology, Inc.

🇺🇸

Westerville, Ohio, United States

UHHS Westlake - Ireland Cancer Center

🇺🇸

Westlake, Ohio, United States

Northwest Medical Specialists, PLLC

🇺🇸

Tacoma, Washington, United States

The University of Texas - M. D. Anderson Cancer Center

🇺🇸

Houston, Texas, United States

Shore Cancer Center

🇺🇸

Nassawadox, Virginia, United States

Cancer Treatment & Research Center

🇺🇸

Bismarck, North Dakota, United States

University of Florida/Jacksonville Faculty Clinic

🇺🇸

Jacksonville, Florida, United States

Lakeland Regional Cancer Center

🇺🇸

Lakeland, Florida, United States

Palm Beach Cancer Institute

🇺🇸

West Palm Beach, Florida, United States

Peachtree Hematology & Oncology Consultants, P. C.

🇺🇸

Fayetteville, Georgia, United States

Little Rock Hematology Oncology Benton

🇺🇸

Benton, Arkansas, United States

Palo Verde Hematology Oncology

🇺🇸

Glendale, Arizona, United States

East Bay Medical Oncology/Hematology Medical Associates, Inc.

🇺🇸

Antioch, California, United States

Bay Area Cancer Research Group

🇺🇸

Concord, California, United States

Beverly Oncology and Imaging Center, Inc.

🇺🇸

Montebello, California, United States

North Valley Hematology Oncology Group

🇺🇸

Mission Hills, California, United States

Rosalba Rodriquez, M. D.

🇺🇸

Chula Vista, California, United States

Beverly Oncology & Imaging

🇺🇸

Montebello, California, United States

Oncology Care Medical Associates, Inc.

🇺🇸

Whittier, California, United States

Clinical Trials and Research Associates, Inc.

🇺🇸

Montebello, California, United States

N. County Oncology Medical

🇺🇸

Oceanside, California, United States

Santa Monica Hematology/Oncology

🇺🇸

Santa Monica, California, United States

Diablo Valley Oncology & Hematology Medical Group, Inc.

🇺🇸

Walnut Creek, California, United States

The Center for Hematology/Oncology

🇺🇸

Delray Beach, Florida, United States

Oncology Physicians

🇺🇸

Clearwater, Florida, United States

Morton Plant Hospital

🇺🇸

Clearwater, Florida, United States

Swedish Covenant Cancer Center

🇺🇸

Chicago, Illinois, United States

St. Mary Medical Center

🇺🇸

Galesburg, Illinois, United States

North Shore Oncology Hematology Associates

🇺🇸

McHenry, Illinois, United States

Galesburg Cottage Hospital

🇺🇸

Galesburg, Illinois, United States

Deerpath Medical Associates

🇺🇸

Lake Forest, Illinois, United States

Cancer Care Center

🇺🇸

New Albany, Indiana, United States

Saint Joseph's Regional Medical Center

🇺🇸

South Bend, Indiana, United States

Associates in Oncology/Hematology, P.C.

🇺🇸

Rockville, Maryland, United States

Kansas City Cancer Center

🇺🇸

Lee's Summit, Missouri, United States

Saint Vincent Hospital/Worcester Medical Center-Paul Seed, R.Ph.D

🇺🇸

Worcester, Massachusetts, United States

Freeman Health System

🇺🇸

Joplin, Missouri, United States

Duluth Clinic

🇺🇸

Duluth, Minnesota, United States

Missouri Cancer Associates

🇺🇸

Columbia, Missouri, United States

University Hospital

🇺🇸

Newark, New Jersey, United States

New York Oncology Hematology, P.C.

🇺🇸

Latham, New York, United States

Carolinas HealthCare System/Carolinas Medical Center

🇺🇸

Charlotte, North Carolina, United States

Carolinas Hematology-Oncology Associates

🇺🇸

Charlotte, North Carolina, United States

Piedmont Hematology Oncology Associates

🇺🇸

Winston Salem, North Carolina, United States

Robert Packer Hospital

🇺🇸

Sayre, Pennsylvania, United States

Guthrie Clinic

🇺🇸

Sayre, Pennsylvania, United States

Vita Hematology Oncology, P.C.

🇺🇸

Bethlehem, Pennsylvania, United States

Hospital of the University of Pennsylvania

🇺🇸

Philadelphia, Pennsylvania, United States

Chattanooga Oncology & Hemtology Associates, P. C.

🇺🇸

Chattanooga, Tennessee, United States

The Sarah Cannon Cancer Center

🇺🇸

Nashville, Tennessee, United States

The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC

🇺🇸

Smyrna, Tennessee, United States

Center for Oncology Research and Treatment, PA

🇺🇸

Richardson, Texas, United States

Southwest Fort Worth Cancer Center

🇺🇸

Fort Worth, Texas, United States

East Tennessee Oncology/Hematology, P.C.

🇺🇸

Knoxville, Tennessee, United States

Hospital de Oncologia Maria Curie

🇦🇷

Capital Federal, Buenos Aires, Argentina

Hospital Britanico de Buenos Aires

🇦🇷

Capital Federal, Buenos Aires, Argentina

West Albury Barker's Pharmacy

🇦🇺

Albury, New South Wales, Australia

Hospital Universitario Austral - Servicio de Oncologia

🇦🇷

Pilar, Buenos Aires, Argentina

Complejo Medico de la Policia Federal Argentina "Churruca-Visca" - Servicio de Oncologia

🇦🇷

Buenos Aires, Argentina

Border Medical Oncology - Murray Valley Private Hospital

🇦🇺

Wodonga, Australia

Santo Andre Diagnostico e Tratamento Ltda

🇧🇷

Santo Andre, SP, Brazil

Nucleo de Oncologia da Bahia

🇧🇷

Salvador, BA, Brazil

Hospital Sao Lucas - PUCRS

🇧🇷

Porto Alegre, RS, Brazil

Instituto Nacional del Cancer - Servicio de Radioterapia

🇨🇱

Santiago, Chile

KH GroBhansdorf - Abt. fuer Thoraxonkologie

🇩🇪

Woehrendamm 80, Grosshansdorf, Germany

St. Vincentius-Kliniken gAG

🇩🇪

Sudendstrasse 32, Karlshure, Germany

Stadtisches Krankenhaus Martha-Maria Halle-Dolau GmbH

🇩🇪

Haale, Germany

Thoraxklinik-Heidelberg GmbH

🇩🇪

Heidelberg, Rohrbach BW, Germany

Bristol Haemotolgy and Oncology Centre

🇬🇧

Bristol, United Kingdom

Cancer Care Associates

🇺🇸

Tulsa, Oklahoma, United States

Baptist Hospital of East Tennessee

🇺🇸

Knoxville, Tennessee, United States

Medical Oncology & Hematology, P. C.

🇺🇸

New Haven, Connecticut, United States

Florida Hospital

🇺🇸

Orlando, Florida, United States

Moroose, Reynolds, Castillo, Robinson & Lukman, MD, PA

🇺🇸

Orlando, Florida, United States

St. Joseph Mercy Hospital, Cancer Center, OC 139

🇺🇸

Ann Arbor, Michigan, United States

Medical University of S.C.

🇺🇸

Charleston, South Carolina, United States

Sharon Hospital

🇺🇸

Sharon, Connecticut, United States

University of Arkansas for Medical Sciences

🇺🇸

Little Rock, Arkansas, United States

Heritage Physician Group, Oncology

🇺🇸

Hot Springs, Arkansas, United States

Charlotte Hungerford Hospital

🇺🇸

Torrington, Connecticut, United States

Highlands Oncology Group

🇺🇸

Springdale, Arkansas, United States

New Milford Hospital

🇺🇸

New Milford, Connecticut, United States

Lakeland Hospital

🇺🇸

St. Joseph, Michigan, United States

Northwestern Connecticut Oncology/Hematology

🇺🇸

Torrington, Connecticut, United States

Georgetown University Hospital

🇺🇸

Washington, District of Columbia, United States

Washington Hospital Center - Washington Cancer Institute

🇺🇸

Washington, District of Columbia, United States

Instituto Alexander flaming

🇦🇷

Buenos Aires, Argentina

H.I.G.A. Eva Peron

🇦🇷

San Martin, Argentina

Fallon Clinic Pharmacy-Linda Tolf, R.Ph.

🇺🇸

Worcester, Massachusetts, United States

Sparrow Health System

🇺🇸

Lansing, Michigan, United States

Nevada Cancer Centers

🇺🇸

Las Vegas, Nevada, United States

Horizons West Medical Group

🇺🇸

Scottsbluff, Nebraska, United States

Cooper Cancer Institute

🇺🇸

Voorhees, New Jersey, United States

The Consultant Group, P.C.

🇺🇸

Nashville, Tennessee, United States

Kaiser Permanente Northwest Region

🇺🇸

Portland, Oregon, United States

Thompson Oncology Group

🇺🇸

Maryville, Tennessee, United States

Cancer Centers of the Carolinas

🇺🇸

Spartanburg, South Carolina, United States

Memorial Hospital

🇺🇸

Chattanooga, Tennessee, United States

Policlinica Privada Instituto de Medicina Nuclear

🇦🇷

Bahia Blanca, Buenos Aires, Argentina

Cumberland Oncology & Hematology

🇺🇸

Oak Ridge, Tennessee, United States

Baptist Hospital West

🇺🇸

Knoxville, Tennessee, United States

VLCC-West Bend

🇺🇸

West Bend, Wisconsin, United States

VLCC-Elkhorn

🇺🇸

Elkhorn, Wisconsin, United States

Aurora Health Center-Slinger

🇺🇸

Slinger, Wisconsin, United States

Hospital Alvarez

🇦🇷

Capital Federal, Buenos Aires, Argentina

Hospital Privado de Comunidad

🇦🇷

Cordoba, Mar del Plata, Argentina

Hospital General de Agudos "Carlos G. Durand" - Servicio de Oncologia

🇦🇷

Buenos Aires, Argentina

Sociedad de Beneficencia Hospital Italiano

🇦🇷

Cordoba, Argentina

Instituto CAICI

🇦🇷

Rosario, Argentina

Hospital Donacion F. Santojanni

🇦🇷

Capital Federal, Buenos Aires, Argentina

Laborgemeinschaft Hamburg

🇩🇪

Lademannbogen 8, Hamburg, Germany

St. Vincent's Hospital

🇦🇺

Fitzroy, Victoria, Australia

Departmento de Hemato-Oncologia

🇨🇱

Santiago, Las Condes, Chile

Instituto Nacional del Cancer

🇨🇱

Santiago, Chile

Allgemeines Krankenhaus St. Georg

🇩🇪

Lohmuehlstr.5, Hamburg, Germany

Pharmatel Fresenius Kabi Pty Ltd.

🇦🇺

West Melbourne, Victoria, Australia

Straub Clinic & Hospital

🇺🇸

Honolulu, Hawaii, United States

Kapiolani Medical Center for Women & Children

🇺🇸

Honolulu, Hawaii, United States

Albert Einstein Cancer Center at the Montefiore Medical Park

🇺🇸

Bronx, New York, United States

The Jack D. Weiler Hospital of the Albert Einstein College of Medicine

🇺🇸

Bronx, New York, United States

North Shore Hematology Oncology Associates, P.C.

🇺🇸

East Setauket, New York, United States

Department Of Oncology

🇦🇺

South Brisbane, Queensland, Australia

Providence Holy Cross Medical Center

🇺🇸

Mission Hills, California, United States

Moroose, Reynolds, Castillo, Robinson & Lukeman, MD, PA

🇺🇸

Altamonte Springs, Florida, United States

Annapolis Oncology Center

🇺🇸

Annapolis, Maryland, United States

Central Jersey Oncology Center

🇺🇸

East Brunswick, New Jersey, United States

Montefiore Medical Center

🇺🇸

Bronx, New York, United States

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