TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

July 21, 2011 updated by: Telik

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.

Study Overview

Status

Completed

Conditions

Ovarian Neoplasms

Intervention / Treatment

Study Type

Interventional

Enrollment

440

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

Argentina
- - Buenos Aires, Argentina, C1181ACH
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Argentina, 1408
    - Hospital Donación Francisco Santojanni
  - Buenos Aires, Argentina, 1437
    - Complejo Medico de la Policia Federal Argentina "Churruca-Visca"
  - Buenos Aires, Argentina, C1405CNF
    - Sanatorio Municipal Dr. Julio Mendez
  - Buenos Aires, Argentina, C1405DCS
    - Hospital General de Agudos "Carlos G. Durand"
  - Buenos Aires, Argentina, C1437JCP
    - Complejo Medico de la Policia Federal Argentina "Churruca-Visca"
  - Buenos Aires, Argentina
    - Hospital de Oncologia Maria Curie
  - Buenos Aires, Argentina
    - Policlínica Privada Instituto de Medicina Nuclear
  - Cordoba, Argentina
    - Sociedad de Beneficencia Hospital Italiano
  - Santa Fe, Argentina, 03000
    - ISIS Clinica Especializada
- Buenos Aires
  - Bahia Blanca, Buenos Aires, Argentina, B8001HXM
    - Hospital Italiano Regional del Sur
  - Capital Federal, Buenos Aires, Argentina, 1408
    - Hospital General de Agudos Donación F. Santojanni
  - Pilar, Buenos Aires, Argentina, B1629AHJ
    - Hospital Universitario Austral
Belgium
- - Brussels, Belgium, 1090
    - AZ-VUB Dienst Oncologie
  - Brussels, Belgium, B 1200
    - Cliniques Universitaires Saint-luc
  - Gent, Belgium, 9000
    - Universitair Ziekenhuis Gent.
  - Liege, Belgium, 4000
    - Centre Hospitalier Régional de la Citadelle
- Antwerpen
  - Lindedreef, Antwerpen, Belgium, 2020
    - Algemeen Ziekenhuis Antwerpen
- Edegem
  - Wilrijkstraat, Edegem, Belgium, 2650
    - Universitaire Ziekenhuis Antwerpen
- Leuven
  - Herestraat, Leuven, Belgium, 49
    - University Hospital Gasthuisberg
Brazil
- - Rio de Janeiro, Brazil, 20220-410
    - INCA Hospital de Oncologia Clinica
  - Sao Paolo, Brazil, 01509
    - Hospital do Cancer - A.C. Camargo
  - Sao Paolo, Brazil
    - Instituto de Saúde e Bem Estar da Mulher
  - Sao Paulo, Brazil, 04024-002
    - Unifesp/Epm
- CE
  - Fortaleza, CE, Brazil, 60430-230
    - Instituto do Cancer do Ceara
- MG
  - Belo Horizonte, MG, Brazil, 30190-130
    - Hospital Vera Cruz
  - Belo Horizonte, MG, Brazil, 32380
    - Hospital Luxemburgo
- PR
  - Curitiba, PR, Brazil
    - Hospital de Clínicas da Universidade Federal do Paraná
  - Londrina, PR, Brazil, 86010-640
    - Centro de Tratamento Oncologico de Londrina
- Porto Alegre
  - Bairro Bom Fim, Porto Alegre, Brazil, 90035-003
    - Hospital de Clinicas de Porto Alegre
- SP
  - Sao Paolo, SP, Brazil, 01223
    - Instituto Arnaldo Vieira de Carvalho
  - Sao Paolo, SP, Brazil, 05403
    - Hospital das Clinicas de Sao Paulo-FMUSP
Chile
- - Santiago de Chile, Chile
    - Clinica Santa Maria
- Santiago
  - Independencia, Santiago, Chile, Santos Dumontt 999
    - Servicio de Oncologia-Hospital Clinico Unversidad de Chile
Czech Republic
- - Brno, Czech Republic, 656 53
    - Masarykuv onkologicky ustav
  - Plzen, Czech Republic
    - Fakultni nemocnice, Onkologicka klinika
- Olomouc
  - Pardubice, Olomouc, Czech Republic, 77520
    - Fakultni nemocnice Olomouc, Onkologicka klinika
- Pardubice
  - Kyjevska 44, Pardubice, Czech Republic, 53203
    - Krajska nemocnice Pardubice, Oddeleni radiacni onklogie
- Plzen
  - Doudlevecka 69, Plzen, Czech Republic, 301 31
    - Fakultni Nemocnice - Onkologicka Klinika
- Praha
  - Unemocnice, Praha, Czech Republic, 12808
    - Vseobecna Fakultni Nemocnice - Onkologicka Klinika
- Zlin
  - Havlickovo nabrezi, Zlin, Czech Republic, 76001
    - Batova krajska nemocnice Zlin, prispevkova organizace, Radiodiagnosticke oddeleni
  - Havlickovo nabrezi 600, Zlin, Czech Republic, 76001
    - Batova krajska nemocnice Zlin, prispevkova organizace, Onkologicke oddeleni
Germany
- - Berlin, Germany, D13353
    - Universitatsklinikum Charite - Campus Virchow-Klinikum
  - Karlsruhe, Germany, D-76137
    - St. Vincentius Kliniken
  - Karlsruhe, Germany, D76137
    - St. Vincentius Kliniken - Frauenkinik
  - Karlsruhe, Germany, D76137
    - St. Vincentius Kliniken - Radiology
  - Munich, Germany, D-81377
    - Klinikum GroBhadern-Institut fur Radiologie
  - Munich, Germany, D81377
    - Klinikum GroBhadern-Zentrum fur Frauenheilkunde
  - Ulm, Germany, D89075
    - Universitaets-Frauenklinik Ulm
  - Wiesbaden, Germany, D65199
    - Dr. Horst-Schmidt-Kliniken GmbH
Hungary
- - Baross, Hungary, H-1088
    - Semmelweis University, 1st Dept. of Obstetrics and Gynaecology
  - Budapest, Hungary, H-1145
    - Uzsoki Street Hospital Dept. of Radiooncology
  - Debrecen, Hungary, 4032
    - Faculty of Gynaecologycal Oncology/Univ. of Debrecen
  - Pecs, Hungary, 7632
    - Baranya County Hospital
  - Rakoczi, Hungary
    - Baranya County Hospital - Department of Oncology
  - Rakoczi, Hungary
    - Baranya County Hospital - Department of Radiology
  - Szeged, Hungary, 6720
    - SZTE, Department of Oncotherapy
Ireland
- - Belfast, Ireland, BT9 7AB
    - Oncology Dept., University Floor, Belfast City Hospital
Netherlands
- - HV Amsterdam, Netherlands, 1081
    - Vrije Universiteit Medical Centre (VUMC)
  - Nijmegen, Netherlands, 6525
    - University Medical Centre Nijmegen (UMCN)
South Africa
- - Port Elizabeth, South Africa, 6001
    - Eastern Cape Oncology Research Centre
- Cape Town
  - Panorama, Cape Town, South Africa, 7500
    - Panorama Medical Centre
- Durban
  - Overport, Durban, South Africa, 4091
    - Hopelands Cancer Centre
- Johannesburg
  - Rosebank, Johannesburg, South Africa, 2196
    - Medical and Dental Centre
  - Saxonwold, Johannesburg, South Africa, 2196
    - Rosebank Oncology Centre
- Pretoria
  - Die Wilgers x14, Pretoria, South Africa, 41
    - Wilgers Oncology Centre
Spain
- - Barcelona, Spain, 08036
    - Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia Medica
  - Barcelona, Spain, 8035
    - Hospital Clinic i Provincial
  - Guadalajara, Spain
    - Hospital General de Guadalajara
  - Madrid, Spain, 28007
    - Servicio de Oncología
  - Valencia, Spain, 46009
    - Instituto Valenciano de Oncologia (IVO) Servicio de Oncologia
  - Valencia, Spain, 46009
    - Instituto Valenciano de Oncologia (IVO) Servicio de Radiologia
- Barcelona
  - Vall d'Hebron, Barcelona, Spain, 119-129
    - Servicio Oncologia Hospital General Vall d'HebronPaseo
- Valencia
  - Profesor Beltran Baguena, Valencia, Spain, 46009
    - Instituto Valenciano de Oncología (IVO)
United Kingdom
- - Birmingham, United Kingdom, B18 7QH
    - St. Chad's Outpatients Unit, City Hospital
  - Bristol, United Kingdom, BS2 8ED
    - United Bristol Healthcare Trust - Bristol Oncology Centre
  - Glasgow, United Kingdom, G11 6NT
    - Beatson Oncology Centre
  - Glasgow, United Kingdom, G11 6NT
    - Beatson Oncology Unit
  - London, United Kingdom, SE1 9RT
    - Medical Oncology - Guy's and St. Thomas' Hospital
  - London, United Kingdom, SW3 6JJ
    - Department of Medicine-Royal Marsden Hospital
  - Manchester, United Kingdom, M20 4BX
    - Department of Medical Oncology, Christie Hospital
  - Newcastle-upon-Tyne, United Kingdom, NE4 6BE
    - Medical Oncology (NCCT) - Newcastle General Hospital
  - Poole, United Kingdom, BH15 2JB
    - Dorset Cancer Centre - Poole Hospital
  - Wales, United Kingdom, CFT142TL
    - Velindre NHS Trust - Velindre Hospital
- Dundee
  - Scotland, Dundee, United Kingdom, DD1 9SY
    - Department of Cancer Medicine - Ninewells Hospital & Medical School
- Surrey
  - Sutton, Surrey, United Kingdom, SMT 5PT
    - Dept. of Med. Oncology/The Royal Marsden Hospital
United States
- Arkansas
  - Little Rock, Arkansas, United States, 72205
    - University of Arkansas for Medical Sciences
  - Little Rock, Arkansas, United States, 72205
    - Little Rock Hematology Oncology Associates
- California
  - Baldwin Park, California, United States, 91706
    - Southern California Permanente Medical Group
  - Burbank, California, United States, 91505-4866
    - Providence Saint Joseph Medical Center
  - Chula Vista, California, United States, 91911
    - Marilyn Norton, M. D.
  - Chula Vista, California, United States, 91911
    - Rosalba Rodriguez, M. D.
  - Concord, California, United States, 94520
    - Bay Area Research Cancer Group
  - Escondido, California, United States, 92025
    - Southwest Cancer Care
  - Fresno, California, United States, 93710
    - California Oncology of the Central Valley
  - Hayward, California, United States, 94545
    - Kaiser Permanente Oncology Clinical Trials Program
  - La Jolla, California, United States, 92037
    - Gynecologic Oncology Associates
  - La Mesa, California, United States, 91942
    - Grossmont Hospital
  - La Mesa, California, United States, 91942
    - Sharp Rees-Stealy
  - Loma Linda, California, United States, 92354
    - Loma Linda University Medical Center
  - Loma Linda, California, United States, 92354
    - LLU Faculty Medical Offices
  - Loma Linda, California, United States, 92354
    - LLU Faculty Meidical Offices
  - Los Angeles, California, United States, 90095
    - David Geffen School of Medicine at UCLA
  - Los Gatos, California, United States, 95032
    - Women's Cancer Center - Community Hospital Los Gatos
  - Murrieta, California, United States, 92562
    - Southwest Cancer Care
  - Newport Beach, California, United States, 92663
    - Gyncologic Oncology Associates
  - Oakland, California, United States, 94611
    - Kaiser Permanente Oncology Clinical Trials Program
  - Oceanside, California, United States, 92056
    - N. County Oncology Medical
  - Poway, California, United States, 92064
    - Southwest Cancer Care
  - Redwood City, California, United States, 94063
    - Kaiser Permanente Oncology Clinical Trials Program
  - Roseville, California, United States, 95661
    - Kaiser Permanente Oncology Clinical Trials Program
  - Sacramento, California, United States, 95825
    - Kaiser Permanente Oncology Clinical Trials Program
  - San Diego, California, United States, 92123
    - Sharp Rees-Stealy
  - San Diego, California, United States, 92123
    - Sharp Memorial Hospital
  - San Diego, California, United States, 92120
    - Southern California Permanente Medical Group
  - San Diego, California, United States, 92123
    - Medical Oncology Associates-SD
  - San Diego, California, United States, 92123
    - Sharp Healthcare Clinical Oncology Research
  - San Francisco, California, United States, 94115
    - Kaiser Permanente Oncology Clinical Trials Program
  - San Rafael, California, United States, 94903
    - Kaiser Permanente Oncology Clinical Trials Program
  - Santa Clara, California, United States, 95051
    - Kaiser Permanente Oncology Clinical Trials Program
  - Santa Rosa, California, United States, 95403
    - Kaiser Permanente Oncology Clinical Trials Program
  - Santa Teresa, California, United States, 95119
    - Kaiser Permanente Oncology Clinical Trails Program
  - South San Francisco, California, United States, 94080
    - Kaiser Permanente Oncology Clinical Trials Program
  - Vallejo, California, United States, 94589
    - Kaiser Permanente Oncology Clinical Trials Program
  - Walnut Creek, California, United States, 94596
    - Kaiser Permanente Oncology Clinial Trials Program
- Connecticut
  - Norwalk, Connecticut, United States, 06856
    - Whittingham Cancer Center at Norwalk Hospital
  - Stamford, Connecticut, United States, 06902
    - Hematology Oncology, P.C.
- Florida
  - Boca Raton, Florida, United States, 33486
    - The Center for Hematology-Oncology
  - Delray Beach, Florida, United States, 33484
    - The Center for Hematology-Oncology
  - Hollywood, Florida, United States, 33021
    - Memorial Regional Hospital
  - Hollywood, Florida, United States, 33021
    - Sheridan Clinical Research, Inc.
  - Jacksonville, Florida, United States, 32209
    - University of Florida Health Science Center/Jacksonville
  - Orlando, Florida, United States, 32803
    - Florida Hospital
  - Orlando, Florida, United States, 32804
    - Gynecologic Oncology
  - Ormond Beach, Florida, United States, 32174
    - Florida Hospital Memorial Division, Cancer Care Center
  - Ormond Beach, Florida, United States, 32174
    - Florida Hospital Memorial Division
  - Palm Beach Gardens, Florida, United States, 33410
    - Palm Beach Cancer Institute
  - Pembroke Pines, Florida, United States, 33028
    - Gynecologic Oncology Associates
  - Port St. Lucie, Florida, United States, 34952
    - Hematology/Oncology Associates of Treasure Coast
  - S. Miami, Florida, United States, 33143
    - Women's Cancer Research Foundation, Inc.
  - Wellington, Florida, United States, 33414
    - Palm Beach Cancer Institute
  - West Palm Beach, Florida, United States, 33401
    - Palm Beach Cancer Institute
- Georgia
  - Duluth, Georgia, United States, 30096
    - Suburban Hematology Oncology
  - Lawrenceville, Georgia, United States, 30045
    - Suburban Hematology-Oncology Associates
  - Savannah, Georgia, United States, 31404
    - Memorial Health University Medical Center
  - Snellville, Georgia, United States, 30078
    - Suburban Hematology Oncology
- Hawaii
  - Honolulu, Hawaii, United States, 96819
    - Kaiser Permanente - Moanalua Medical Center
  - Honolulu, Hawaii, United States, 96826
    - Straub Clinic and Hospital
  - Honolulu, Hawaii, United States, 96826
    - Univ. of Hawaii, Kapiolani Medical Center for Women and Children
- Illinois
  - Barrington, Illinois, United States, 60010
    - North Shore Oncology Hematology Associates
  - Berwyn, Illinois, United States, 60402
    - MacNeal Cancer Center
  - Chicago, Illinois, United States, 60625
    - Swedish Covenant Cancer Center
  - Chicago, Illinois, United States, 60657
    - Hematology Oncology Associates of Illinois (HOAI)
  - Decatur, Illinois, United States, 62526
    - Decatur Memorial Hospital
  - Decatur, Illinois, United States, 62526
    - Cancer Care Specialists of Central IL
  - Effingham, Illinois, United States, 62401
    - Cancer Care Specialists of Central IL-Crossroads Cancer Care Center
  - Flossmoor, Illinois, United States, 60422
    - Joliet Oncology-Hematology Associates, Ltd.
  - Joliet, Illinois, United States, 60435
    - Joliet Oncology-Hematology Associates, Ltd.
  - Lake Forest, Illinois, United States, 60045
    - North Shore Oncology Hematology Associates - Deerpath Medical Associates
  - Libertyville, Illinois, United States, 60048
    - North Shore Oncology Hematology Associates
  - McHenry, Illinois, United States, 60050
    - North Shore Oncology Hematology Associates
  - Morris, Illinois, United States, 60450
    - Joliet Oncology-Hematology Associates, Ltd.
  - Skokie, Illinois, United States, 60076
    - Hematology Oncology Associates of Illinois (HOAI)
  - Skokie, Illinois, United States, 60077
    - Midwest Cancer Research Group, Inc.
- Indiana
  - Elkhart, Indiana, United States, 46514
    - Elkhart General Hospital
  - Elkhart, Indiana, United States, 46514
    - Michiana Hematology Oncology
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Medical Center
  - Indianapolis, Indiana, United States, 46260
    - St. Vincent Hospital and Health Care Center
  - Indianapolis, Indiana, United States, 46260
    - St. Vincent Gynecologic Oncology
  - Indianapolis, Indiana, United States, 46202
    - Indiana Cancer Pavilion
  - Indianapolis, Indiana, United States, 46260
    - St. Vincent Hospital and Helath Care Center
  - South Bend, Indiana, United States, 46617
    - Michiana Hematology Oncology
  - South Bend, Indiana, United States, 46617
    - St. Joseph's Regional
  - South Bend, Indiana, United States, 46634
    - Saint Joseph's Regional
- Iowa
  - Iowa City, Iowa, United States, 52242
    - University of Iowa Hospitals and Clinics
  - Iowa City, Iowa, United States, 52242
    - University of Iowa
- Kansas
  - Wichita, Kansas, United States, 67208
    - Research Support Personnel, LLC
  - Wichita, Kansas, United States, 67214
    - Associates in Women's Health
- Kentucky
  - Crestview, Kentucky, United States, 41017
    - Oncology/Hematology Care, Inc.
  - Louisville, Kentucky, United States, 40202
    - Univ. of Louisville, Div. of Gynecologic Oncology
- Louisiana
  - Covington, Louisiana, United States, 70433
    - Hematology And Oncology Specialists, Llc
  - Metairie, Louisiana, United States, 70002
    - OncRx (Pharmacy)
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
  - New Orleans, Louisiana, United States, 70115
    - Hematology And Oncology Specialists, Llc
  - Shreveport, Louisiana, United States, 71103
    - LSU Health Sciences Center
- Maryland
  - Baltimore, Maryland, United States, 21205
    - Sinai Cancer Institute
  - Bethesda, Maryland, United States, 20817
    - Center for Cancer and Blood Disorders
- Massachusetts
  - Boston, Massachusetts, United States, 02135
    - St. Elizabeth's Med. Ctr.
- Michigan
  - Ann Arbor, Michigan, United States, 48106
    - St. Joseph Mercy Hospital
  - Lansing, Michigan, United States, 48909
    - Sparrow Regional Cancer Center
- Minnesota
  - Duluth, Minnesota, United States, 55805
    - St. Mary's Duluth Clinic
- Missouri
  - Columbia, Missouri, United States, 65203
    - Ellis Fischel Cancer Center
  - St. Louis, Missouri, United States, 63117
    - St. Louis University, Dept. of Ob-Gyn and Women's Health
  - St. Louis, Missouri, United States, 63141
    - Gynecology & Oncology Consultants, PC
  - St. Louis, Missouri, United States, 63141
    - Saint John's Mercy Hospital
- Montana
  - Billings, Montana, United States, 59101
    - Deaconess Billings Clinic
  - Billings, Montana, United States, 59101
    - Hematology & Oncology Centers Northern Rockies
  - Butte, Montana, United States, 59701
    - Hematology Oncology Centers of the Northern Rockies
- Nebraska
  - Scottsbluff, Nebraska, United States, 69361
    - Horizon's West Medical Group
- Nevada
  - Las Vegas, Nevada, United States, 89109
    - Nevada Cancer Center
- New Jersey
  - Neptune, New Jersey, United States, 07754
    - Jersey Shore University Medical Center
  - New Brunswick, New Jersey, United States, 08901
    - The Cancer Institute of New Jersey
  - New Brunswick, New Jersey, United States, 08903
    - Robert Wood Johnson University Hospital
- New Mexico
  - Albuquerque, New Mexico, United States, 87131
    - UNM Cancer Research and Treatment Center
- New York
  - Babylon, New York, United States, 11702
    - Benjamin Schwartz, M.D.
  - Cooperstown, New York, United States, 13326
    - The Mary Imogene Bassett Hospital
  - Malone, New York, United States, 12953
    - Med-Onc/Hem
  - New City, New York, United States, 10956
    - Hematology-Oncology Associates of Rockland
  - New Hyde Park, New York, United States, 11040
    - Long Island Jewish Medical Center
  - New Hyde Park, New York, United States, 11040
    - North Shore-Long Island Jewish Health System/Medical Center
  - New York, New York, United States, 10016
    - Bellevue Hospital Center
  - New York, New York, United States, 10016
    - NYU School of Medicine
  - New York, New York, United States, 10016
    - Comprehensive Cancer Center Medical Practice Offices
  - New York, New York, United States, 10016
    - New York University Medical Center - Tisch Hospital
  - New York, New York, United States, 11021
    - Memorial Sloan Kettering Cancer Center
  - Nyack, New York, United States, 10960
    - The Union State Bank Cancer Center at Nyack Hospital
  - Rochester, New York, United States, 14620
    - Gynecologic-Oncology
  - West Islip, New York, United States, 11795
    - Good Samaritan Hospital Medical Center
  - West Islip, New York, United States, 11795
    - South Bay OB/GYN
- North Carolina
  - Charlotte, North Carolina, United States, 28204
    - Presbyterian Hospital Center for Cancer Research
  - Charlotte, North Carolina, United States, 28203
    - Blumenthal Cancer Center
  - Charlotte, North Carolina, United States, 28204
    - Presbyterian Gynecologic Oncology
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University School of Medicine
  - Winston-Salem, North Carolina, United States, 27103
    - Piedmont Hematology Oncology Assoc., PA-Salem Research Group
  - Winston-Salem, North Carolina, United States, 27103
    - Salem Research Group, Inc.
- North Dakota
  - Bismarck, North Dakota, United States, 58501
    - Mid Dakota Clinic
  - Bismarck, North Dakota, United States, 58501
    - Odyssey Research Services
  - Fargo, North Dakota, United States, 58103
    - Dakota Cancer Institute
  - Fargo, North Dakota, United States, 58104
    - Odyssey Research Services
- Ohio
  - Cincinnati, Ohio, United States, 45242
    - Oncology/Hematology Care, Inc.
  - Cincinnati, Ohio, United States, 45219
    - Barrett Cancer Center
  - Cincinnati, Ohio, United States, 45219
    - University Hospital
  - Cincinnati, Ohio, United States, 45013
    - Oncology/Hematology Care, Inc.
  - Cincinnati, Ohio, United States, 45219-0501
    - Barrett Cancer Center
  - Cincinnati, Ohio, United States, 45219
    - Oncology/Hematology Care, Inc.
  - Cincinnati, Ohio, United States, 45219
    - UC Physician's Medical Arts Bldg.
  - Cincinnati, Ohio, United States, 45219
    - UC Physician's Medical Arts Building
  - Cincinnati, Ohio, United States, 45230
    - Oncology/Hematology Care, Inc.
  - Cincinnati, Ohio, United States, 45236
    - Oncology/Hematology Care, Inc.
  - Cleveland, Ohio, United States, 44109
    - MetroHealth Medical Center
  - Cleveland, Ohio, United States, 44109
    - Metro Health Medical Center
  - Columbus, Ohio, United States, 43081
    - Mid-Ohio Oncology Hematology St. Anne's
  - Columbus, Ohio, United States, 43213
    - Mid Ohio Oncology Hematology
  - Columbus, Ohio, United States, 43213
    - Mid-Ohio Oncology Hematology
  - Columbus, Ohio, United States, 43222
    - Gynecologic Oncology
  - Columbus, Ohio, United States, 43222
    - Mount Carmel Health
  - Dayton, Ohio, United States, 45409
    - Wright State Univ. School of Medicine
  - Mayfield Heights, Ohio, United States, 44124
    - Hillcrest Hospital Cancer Center
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
  - Oklahoma City, Oklahoma, United States, 73104
    - OU Medical Center - Everett Tower
  - Oklahoma City, Oklahoma, United States, 73104
    - OU Physicians' Bldg.
  - Oklahoma City, Oklahoma, United States, 73104
    - Presbyterian
- Oregon
  - Portland, Oregon, United States, 97239
    - Oregon Health Science University
  - Portland, Oregon, United States, 97239-3098
    - Oregon Health & Science University
  - Portland, Oregon, United States, 97227
    - Kaiser Permanente Nw, Oncology Research
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Mem. Hospita/Rosenfield Cancer Center
  - Dunmore, Pennsylvania, United States, 18512
    - Advanced Imaging
  - Dunmore, Pennsylvania, United States, 18512
    - Hematology & Oncology Associates of NEPA
  - Pittsburgh, Pennsylvania, United States, 15213
    - Magee-Womens Hospital
  - Scranton, Pennsylvania, United States, 18510
    - Community Medical Center
  - Scranton, Pennsylvania, United States, 18510
    - Moses Taylor Hospital
  - Scranton, Pennsylvania, United States, 18508
    - Viewmont Medical Services
  - Scranton, Pennsylvania, United States, 18510
    - Mercy Health Partners
  - Upland, Pennsylvania, United States, 19013
    - Associates in Hematology-Oncology, P.C.
- South Carolina
  - Charleston, South Carolina, United States, 29407
    - Carolina Center of Gynecologic Oncology, PA
  - Columbia, South Carolina, United States, 29201
    - South Carolina Oncology Associates, PA
  - Greenville, South Carolina, United States, 29605
    - Gynecologic Oncology Research and Development
  - Spartanburg, South Carolina, United States, 29303
    - Gynecologic Oncology Research and Development
- South Dakota
  - Sioux Falls, South Dakota, United States, 57104
    - Sioux Valley Clinic Clinical Research Center
  - Sioux Falls, South Dakota, United States, 57104
    - Sioux Valley Clinic Oncology
  - Sioux Falls, South Dakota, United States, 57104
    - Sioux Valley Hospital - North Center Radiology
  - Sioux Falls, South Dakota, United States, 57105
    - Sioux Calley Clinic OBGYN Ltd.
- Tennessee
  - Chattanooga, Tennessee, United States, 37404
    - Memorial Hospital
  - Chattanooga, Tennessee, United States, 37404
    - Chattanooga Oncology & Hematology Associates, P.C.
  - Franklin, Tennessee, United States, 37067
    - The Consultant Group
  - Gallatin, Tennessee, United States, 37066
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Hermitage, Tennessee, United States, 37076
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Knoxville, Tennessee, United States, 37917
    - Saint Mary's Health System, Inc.
  - Knoxville, Tennessee, United States, 37920
    - Hall and Martin, M.D.'s, P.C.
  - Knoxville, Tennessee, United States, 37923
    - Fort Sanders Parkwest Medical Center
  - Lebanon, Tennessee, United States, 37087
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Murfreesboro, Tennessee, United States, 37130
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37203
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37205
    - The Consultant Group
  - Nashville, Tennessee, United States, 37205
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37207
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Nashville, Tennessee, United States, 37211
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
  - Smyma, Tennessee, United States, 37167
    - The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC
- Texas
  - Amarillo, Texas, United States, 79106
    - Amarillo Cancer Center
  - Arlington, Texas, United States, 76012
    - Arlington Cancer Center
  - Dallas, Texas, United States, 75231
    - Texas Cancer Associates
  - Dallas, Texas, United States, 75201
    - Dallas Oncology Consultants
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology, PA
  - Fort Worth, Texas, United States, 76132
    - Southwest Fort Worth Cancer Center
  - Houston, Texas, United States, 77030
    - Univ. of TX, MD Anderson Cancer Center
- Virginia
  - Danville, Virginia, United States, 24541
    - Danville Hematology and Oncology, Inc.
- Washington
  - Aberdeen, Washington, United States, 98520
    - Western Washington Oncology
  - Centralia, Washington, United States, 98531
    - Western Washington Oncology
  - Covington, Washington, United States, 98042
    - Covington MultiCare - Oncology Clinic
  - Olympia, Washington, United States, 98502
    - Western Washington Oncology
  - Olympia, Washington, United States, 98506
    - Western Washington Oncology
  - Shelton, Washington, United States, 98584
    - Western Washington Oncology
  - Tacoma, Washington, United States, 98405
    - Allenmore Hospital - Hematology Oncology Clinic
  - Tacoma, Washington, United States, 98405
    - MultiCare Health System - Medical Oncology
- Wisconsin
  - Chippewa Falls, Wisconsin, United States, 54729
    - Chippewa Falls Cancer Center
  - Eau Claire, Wisconsin, United States, 54701
    - Regional Cancer Center
  - Marshfield, Wisconsin, United States, 54449
    - Saint Joseph's Hospital
  - Marshfield, Wisconsin, United States, 54449
    - Marshfield Clinic Research Foundation
  - Marshfield, Wisconsin, United States, 54494
    - Wisconsin Rapid Cancer Center
  - Merrill, Wisconsin, United States, 54452
    - Merrill Cancer Center
  - Milwaukee, Wisconsin, United States, 53215
    - Medical Consultants, Ltd.
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinic - Lakeland Center
  - Minocqua, Wisconsin, United States, 54548
    - Marshfield Clinc - Lakeland Center
  - Rice Lake, Wisconsin, United States, 54868
    - Marshfield Clinic - Indianhead Center
  - Rice Lake, Wisconsin, United States, 54868
    - Diagnostic Radiology Associates
  - Rice Lake, Wisconsin, United States, 54868
    - Lakeview Medical Center
  - Stevens Point, Wisconsin, United States, 54481
    - Saint Michael Hospital
  - Wausau, Wisconsin, United States, 54401
    - Wausau Cancer Center
- Wyoming
  - Cody, Wyoming, United States, 82414
    - Hematology Oncology Centers of the Northern Rockies
  - Sheridan, Wyoming, United States, 82801
    - Hematology Oncology of the Northern Rockies

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

Female

Description

Inclusion criteria include:

Considered platinum refractory or resistant according to standard criteria
Progressed during or following completion of one second-line treatment with Doxil/Caelyx or Hycamtin
Histologically or cytologically confirmed diagnosis of epithelial cancer of the ovary, fallopian tube, or primary peritoneal cancer
Measurable disease according to RECIST criteria with documented tumor progression

Exclusion criteria include:

Treatment with second-line chemotherapy other than Doxil/Caelyx or Hycamtin
History of whole pelvis radiation therapy within 12 months of enrollment
Clinically significant cardiac disease
Evidence of gross hematuria at the time of study entry
Any signs of intestinal obstruction interfering with nutrition at the time of study entry
Pregnant or lactating women

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
Masking: None (Open Label)

Collaborators and Investigators

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

Sponsor

Telik

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

June 1, 2003

Primary Completion (Actual)

December 1, 2006

Study Completion (Actual)

December 1, 2006

Study Registration Dates

First Submitted

April 7, 2003

First Submitted That Met QC Criteria

April 7, 2003

First Posted (Estimate)

April 8, 2003

Study Record Updates

Last Update Posted (Estimate)

July 25, 2011

Last Update Submitted That Met QC Criteria

July 21, 2011

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

ovary

Additional Relevant MeSH Terms

Other Study ID Numbers

TLK286.3017

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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Completed

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United States
Barbara Ann Karmanos Cancer Institute
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Completed

Folate Receptor in Diagnosing Ovarian Cancer Using Serum Samples From Patients With Newly Diagnosed Pelvic Mass or Previously Diagnosed Ovarian Cancer

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United States
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Study Into a New Diagnostic Tool (Simple Ultrasound-based Rules) in Patients With Adnexal Masses (SUBSONiC)

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Netherlands
Centre Leon Berard
Cancer Côte d'or registry; Cancer Calvados registry

Unknown

Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France (Ovaire01)

Ovarian Epithelial Cancer

France
Gynecologic Oncology Group
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Study of Tumor Tissue Samples From Patients Who Have Undergone Surgery for Advanced Stage III or Stage IV Ovarian Epithelial Cancer

Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer

United States
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Efficacy and Safety of Involving Field Radiotherapy in the Oligo-lesions(Metastasis/Recurrent/Refractory) of Ovarian Cancer

Ovarian Cancer | Cancer of the Ovary | Ovarian Neoplasm | Ovary Cancer | Neoplasms, Ovarian | Ovary Neoplasms | Ovary Neoplasm | Cancer of Ovary | Cancer, Ovarian | Ovarian Cancers | Neoplasm, Ovarian | Neoplasm, Ovary | Neoplasms, Ovary | Cancer, Ovarian Stromal | Cancers, Ovary | Ovary Cancers | Cancers, Ovarian

China
City of Hope Medical Center
National Cancer Institute (NCI)

Completed

Survivorship Care Planning in Improving Quality of Life in Survivors of Ovarian Cancer

Cancer Survivor | Stage IIIA Ovarian Epithelial Cancer | Stage IIIB Ovarian Epithelial Cancer | Stage IIIC Ovarian Epithelial Cancer | Stage IIA Ovarian Epithelial Cancer | Stage IIB Ovarian Epithelial Cancer | Stage IIC Ovarian Epithelial Cancer | Stage IA Ovarian Epithelial Cancer | Stage IB Ovarian... and other conditions

United States
University of Washington
National Cancer Institute (NCI)

Completed

Taking Care of Her Program in Patients With Stage III or IV Ovarian Cancer and Spouse Caregivers

Caregiver | Stage IIIA Ovarian Cancer | Stage IIIB Ovarian Cancer | Stage IIIC Ovarian Cancer | Stage IV Ovarian Cancer

United States
University of Washington
National Cancer Institute (NCI)

Completed

Denileukin Diftitox Used in Treating Patients With Advanced Refractory Ovarian Cancer, Primary Peritoneal Carcinoma, or Epithelial Fallopian Tube Cancer

Fallopian Tube Cancer | Peritoneal Cavity Cancer | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Stage IV Ovarian Epithelial Cancer | Recurrent Ovarian Epithelial Cancer | Stage III Ovarian Epithelial Cancer | Ovarian Mucinous Cystadenocarcinoma and other conditions

United States
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National Institutes of Health (NIH)

Recruiting

A Study of Isoquercetin in People With Ovarian Cancer

Ovarian Cancer | Epithelial Ovarian Cancer | Serous Ovarian Tumor

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Telik

Completed

Study of Canfosfamide in Refractory or Relapsed Mantle Cell, Diffuse Large B Cell Lymphoma and Multiple Myeloma

Multiple Myeloma | B Cell Lymphoma | Mantle Cell Lymphoma

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Telik

Completed

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

Non Small Cell Lung Carcinoma

United States, Australia, Brazil, Chile, Germany, Argentina, Italy, United Kingdom
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Completed

Study of TLK199 HCl Liposomes for Injection in Myelodysplastic Syndrome

Myelodysplastic Syndromes

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Study of ZG0895.HCl in Patients With Advanced Solid Tumors

Advanced Solid Tumor

China
Acrotech Biopharma Inc.

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PK Study of Melphalan HCL & Alkeran for Injection of MA Conditioning in MM Patients of Autologous Transplantation

Multiple Myeloma

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Telik

Completed

TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer

Ovarian Neoplasms

United States
Norgine

Completed

Study to Evaluate the Safety of Post-Operative TZP-101 (IV Ulimorelin) After Partial Bowel Resection

Postoperative Ileus
Bio-Thera Solutions

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A Multicenter Open Clinical Study of Safety, Tolerability, Pharmacokinetic Profile, and Initial Clinical Efficacy of BAT 8010 for Injection Combined With BAT 1006 in the Treatment of Locally Advanced or Metastatic Tumors

Advanced Solid Tumors

China
Changchun GeneScience Pharmaceutical Co., Ltd.

Completed

A Bioequivalence Study of Two Different Dosage Form of Genakumab

Gouty Arthritis (GA)

China
China National Biotec Group Company Limited
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Smallpox | Monkeypox | Poxvirus Infection | Cowpox

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TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer

Phase 3 Randomized Study of TLK286 (Telcyta) Versus Doxil/Caelyx or Hycamtin as Third-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-1 (Assessment of Survival In Solid Tumors-1)]

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Estimate)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on Ovarian Neoplasms

Clinical Trials on TLK286 HCl for injection

Search Similar Trials

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