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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00057720
Other study ID # TLK286.3017
Secondary ID
Status Completed
Phase Phase 3
First received April 7, 2003
Last updated July 21, 2011
Start date June 2003
Est. completion date December 2006

Study information

Verified date May 2006
Source Telik
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Other known NCT identifiers
  • NCT00078884

Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date December 2006
Est. primary completion date December 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

Drug:
TLK286 HCl for injection

topotecan hydrochloride for injection

doxorubicin HCl liposome injection


Locations

Country Name City State
Argentina Hospital Italiano Regional del Sur Bahia Blanca Buenos Aires
Argentina Complejo Medico de la Policia Federal Argentina "Churruca-Visca" Buenos Aires
Argentina Complejo Medico de la Policia Federal Argentina "Churruca-Visca" Buenos Aires
Argentina Hospital de Oncologia Maria Curie Buenos Aires
Argentina Hospital Donacion Francisco Santojanni Buenos Aires
Argentina Hospital General de Agudos "Carlos G. Durand" Buenos Aires
Argentina Hospital Italiano de Buenos Aires Buenos Aires
Argentina Policlinica Privada Instituto de Medicina Nuclear Buenos Aires
Argentina Sanatorio Municipal Dr. Julio Mendez Buenos Aires
Argentina Hospital General de Agudos Donacion F. Santojanni Capital Federal Buenos Aires
Argentina Sociedad de Beneficencia Hospital Italiano Cordoba
Argentina Hospital Universitario Austral Pilar Buenos Aires
Argentina ISIS Clinica Especializada Santa Fe
Belgium AZ-VUB Dienst Oncologie Brussels
Belgium Cliniques Universitaires Saint-Luc Brussels
Belgium Universitair Ziekenhuis Gent. Gent
Belgium University Hospital Gasthuisberg Herestraat Leuven
Belgium Centre Hospitalier Regional de la Citadelle Liege
Belgium Algemeen Ziekenhuis Antwerpen Lindedreef Antwerpen
Belgium Universitaire Ziekenhuis Antwerpen Wilrijkstraat Edegem
Brazil Hospital de Clinicas de Porto Alegre Bairro Bom Fim Porto Alegre
Brazil Hospital Luxemburgo Belo Horizonte MG
Brazil Hospital Vera Cruz Belo Horizonte MG
Brazil Hospital de Clinicas da Universidade Federal do Parana Curitiba PR
Brazil Instituto do Cancer do Ceara Fortaleza CE
Brazil Centro de Tratamento Oncologico de Londrina Londrina PR
Brazil INCA Hospital de Oncologia Clinica Rio de Janeiro
Brazil Hospital das Clinicas de Sao Paulo-FMUSP Sao Paolo SP
Brazil Hospital do Cancer - A.C. Camargo Sao Paolo
Brazil Instituto Arnaldo Vieira de Carvalho Sao Paolo SP
Brazil Instituto de Saude e Bem Estar da Mulher Sao Paolo
Brazil Unifesp/Epm Sao Paulo
Chile Servicio de Oncologia-Hospital Clinico Unversidad de Chile Independencia Santiago
Chile Clinica Santa Maria Santiago de Chile
Czech Republic Masarykuv Onkologicky Ustav Brno
Czech Republic Fakultni Nemocnice - Onkologicka Klinika Doudlevecka 69 Plzen
Czech Republic Batova krajska nemocnice Zlin, prispevkova organizace, Radiodiagnosticke oddeleni Havlickovo nabrezi Zlin
Czech Republic Batova krajska nemocnice Zlin, prispevkova organizace, Onkologicke oddeleni Havlickovo nabrezi 600 Zlin
Czech Republic Krajska nemocnice Pardubice, Oddeleni radiacni onklogie Kyjevska 44 Pardubice
Czech Republic Fakultni nemocnice Olomouc, Onkologicka klinika Pardubice Olomouc
Czech Republic Fakultni nemocnice, Onkologicka klinika Plzen
Czech Republic Vseobecna Fakultni Nemocnice - Onkologicka Klinika Unemocnice Praha
Germany Universitatsklinikum Charite - Campus Virchow-Klinikum Berlin
Germany St. Vincentius Kliniken Karlsruhe
Germany St. Vincentius Kliniken - Frauenkinik Karlsruhe
Germany St. Vincentius Kliniken - Radiology Karlsruhe
Germany Klinikum GroBhadern-Institut fur Radiologie Munich
Germany Klinikum GroBhadern-Zentrum fur Frauenheilkunde Munich
Germany Universitaets-Frauenklinik Ulm Ulm
Germany Dr. Horst-Schmidt-Kliniken GmbH Wiesbaden
Hungary Semmelweis University, 1st Dept. of Obstetrics and Gynaecology Baross
Hungary Uzsoki Street Hospital Dept. of Radiooncology Budapest
Hungary Faculty of Gynaecologycal Oncology/Univ. of Debrecen Debrecen
Hungary Baranya County Hospital Pecs
Hungary Baranya County Hospital - Department of Oncology Rakoczi
Hungary Baranya County Hospital - Department of Radiology Rakoczi
Hungary SZTE, Department of Oncotherapy Szeged
Ireland Oncology Dept., University Floor, Belfast City Hospital Belfast
Netherlands Vrije Universiteit Medical Centre (VUMC) HV Amsterdam
Netherlands University Medical Centre Nijmegen (UMCN) Nijmegen
South Africa Wilgers Oncology Centre Die Wilgers x14 Pretoria
South Africa Hopelands Cancer Centre Overport Durban
South Africa Panorama Medical Centre Panorama Cape Town
South Africa Eastern Cape Oncology Research Centre Port Elizabeth
South Africa Medical and Dental Centre Rosebank Johannesburg
South Africa Rosebank Oncology Centre Saxonwold Johannesburg
Spain Hospital Clinic i Provincial Barcelona
Spain Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia Medica Barcelona
Spain Hospital General de Guadalajara Guadalajara
Spain Servicio de Oncologia Madrid
Spain Instituto Valenciano de Oncologia (IVO) Profesor Beltran Baguena Valencia
Spain Instituto Valenciano de Oncologia (IVO) Servicio de Oncologia Valencia
Spain Instituto Valenciano de Oncologia (IVO) Servicio de Radiologia Valencia
Spain Servicio Oncologia Hospital General Vall d'HebronPaseo Vall d'Hebron Barcelona
United Kingdom St. Chad's Outpatients Unit, City Hospital Birmingham
United Kingdom United Bristol Healthcare Trust - Bristol Oncology Centre Bristol
United Kingdom Beatson Oncology Centre Glasgow
United Kingdom Beatson Oncology Unit Glasgow
United Kingdom Department of Medicine-Royal Marsden Hospital London
United Kingdom Medical Oncology - Guy's and St. Thomas' Hospital London
United Kingdom Department of Medical Oncology, Christie Hospital Manchester
United Kingdom Medical Oncology (NCCT) - Newcastle General Hospital Newcastle-upon-Tyne
United Kingdom Dorset Cancer Centre - Poole Hospital Poole
United Kingdom Department of Cancer Medicine - Ninewells Hospital & Medical School Scotland Dundee
United Kingdom Dept. of Med. Oncology/The Royal Marsden Hospital Sutton Surrey
United Kingdom Velindre NHS Trust - Velindre Hospital Wales
United States Western Washington Oncology Aberdeen Washington
United States Abington Mem. Hospita/Rosenfield Cancer Center Abington Pennsylvania
United States UNM Cancer Research and Treatment Center Albuquerque New Mexico
United States Amarillo Cancer Center Amarillo Texas
United States St. Joseph Mercy Hospital Ann Arbor Michigan
United States Arlington Cancer Center Arlington Texas
United States Benjamin Schwartz, M.D. Babylon New York
United States Southern California Permanente Medical Group Baldwin Park California
United States Sinai Cancer Institute Baltimore Maryland
United States North Shore Oncology Hematology Associates Barrington Illinois
United States MacNeal Cancer Center Berwyn Illinois
United States Center for Cancer and Blood Disorders Bethesda Maryland
United States Deaconess Billings Clinic Billings Montana
United States Hematology & Oncology Centers Northern Rockies Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Odyssey Research Services Bismarck North Dakota
United States The Center for Hematology-Oncology Boca Raton Florida
United States St. Elizabeth's Med. Ctr. Boston Massachusetts
United States Providence Saint Joseph Medical Center Burbank California
United States Hematology Oncology Centers of the Northern Rockies Butte Montana
United States Western Washington Oncology Centralia Washington
United States Carolina Center of Gynecologic Oncology, PA Charleston South Carolina
United States Blumenthal Cancer Center Charlotte North Carolina
United States Presbyterian Gynecologic Oncology Charlotte North Carolina
United States Presbyterian Hospital Center for Cancer Research Charlotte North Carolina
United States Chattanooga Oncology & Hematology Associates, P.C. Chattanooga Tennessee
United States Memorial Hospital Chattanooga Tennessee
United States Hematology Oncology Associates of Illinois (HOAI) Chicago Illinois
United States Swedish Covenant Cancer Center Chicago Illinois
United States Chippewa Falls Cancer Center Chippewa Falls Wisconsin
United States Marilyn Norton, M. D. Chula Vista California
United States Rosalba Rodriguez, M. D. Chula Vista California
United States Barrett Cancer Center Cincinnati Ohio
United States Barrett Cancer Center Cincinnati Ohio
United States Oncology/Hematology Care, Inc. Cincinnati Ohio
United States Oncology/Hematology Care, Inc. Cincinnati Ohio
United States Oncology/Hematology Care, Inc. Cincinnati Ohio
United States Oncology/Hematology Care, Inc. Cincinnati Ohio
United States Oncology/Hematology Care, Inc. Cincinnati Ohio
United States UC Physician's Medical Arts Bldg. Cincinnati Ohio
United States UC Physician's Medical Arts Building Cincinnati Ohio
United States University Hospital Cincinnati Ohio
United States Metro Health Medical Center Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Hematology Oncology Centers of the Northern Rockies Cody Wyoming
United States Ellis Fischel Cancer Center Columbia Missouri
United States South Carolina Oncology Associates, PA Columbia South Carolina
United States Gynecologic Oncology Columbus Ohio
United States Mid Ohio Oncology Hematology Columbus Ohio
United States Mid-Ohio Oncology Hematology Columbus Ohio
United States Mid-Ohio Oncology Hematology St. Anne's Columbus Ohio
United States Mount Carmel Health Columbus Ohio
United States Bay Area Research Cancer Group Concord California
United States The Mary Imogene Bassett Hospital Cooperstown New York
United States Covington Multicare - Oncology Clinic Covington Washington
United States Hematology and Oncology Specialists, LLC Covington Louisiana
United States Oncology/Hematology Care, Inc. Crestview Kentucky
United States Dallas Oncology Consultants Dallas Texas
United States Texas Cancer Associates Dallas Texas
United States Danville Hematology and Oncology, Inc. Danville Virginia
United States Wright State Univ. School of Medicine Dayton Ohio
United States Cancer Care Specialists of Central IL Decatur Illinois
United States Decatur Memorial Hospital Decatur Illinois
United States The Center for Hematology-Oncology Delray Beach Florida
United States St. Mary's Duluth Clinic Duluth Minnesota
United States Suburban Hematology Oncology Duluth Georgia
United States Advanced Imaging Dunmore Pennsylvania
United States Hematology & Oncology Associates of NEPA Dunmore Pennsylvania
United States Regional Cancer Center Eau Claire Wisconsin
United States Cancer Care Specialists of Central IL-Crossroads Cancer Care Center Effingham Illinois
United States Elkhart General Hospital Elkhart Indiana
United States Michiana Hematology Oncology Elkhart Indiana
United States Southwest Cancer Care Escondido California
United States Dakota Cancer Institute Fargo North Dakota
United States Odyssey Research Services Fargo North Dakota
United States Joliet Oncology-Hematology Associates, Ltd. Flossmoor Illinois
United States Southwest Fort Worth Cancer Center Fort Worth Texas
United States Texas Oncology, PA Fort Worth Texas
United States The Consultant Group Franklin Tennessee
United States California Oncology of the Central Valley Fresno California
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Gallatin Tennessee
United States Gynecologic Oncology Research and Development Greenville South Carolina
United States Kaiser Permanente Oncology Clinical Trials Program Hayward California
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Hermitage Tennessee
United States Memorial Regional Hospital Hollywood Florida
United States Sheridan Clinical Research, Inc. Hollywood Florida
United States Kaiser Permanente - Moanalua Medical Center Honolulu Hawaii
United States Straub Clinic and Hospital Honolulu Hawaii
United States Univ. of Hawaii, Kapiolani Medical Center for Women and Children Honolulu Hawaii
United States Univ. of TX, MD Anderson Cancer Center Houston Texas
United States Indiana Cancer Pavilion Indianapolis Indiana
United States Indiana University Medical Center Indianapolis Indiana
United States St. Vincent Gynecologic Oncology Indianapolis Indiana
United States St. Vincent Hospital and Health Care Center Indianapolis Indiana
United States St. Vincent Hospital and Helath Care Center Indianapolis Indiana
United States University of Iowa Iowa City Iowa
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States University of Florida Health Science Center/Jacksonville Jacksonville Florida
United States Joliet Oncology-Hematology Associates, Ltd. Joliet Illinois
United States Fort Sanders Parkwest Medical Center Knoxville Tennessee
United States Hall and Martin, M.D.'s, P.C. Knoxville Tennessee
United States Saint Mary's Health System, Inc. Knoxville Tennessee
United States Gynecologic Oncology Associates La Jolla California
United States Grossmont Hospital La Mesa California
United States Sharp Rees-Stealy La Mesa California
United States North Shore Oncology Hematology Associates - Deerpath Medical Associates Lake Forest Illinois
United States Sparrow Regional Cancer Center Lansing Michigan
United States Nevada Cancer Center Las Vegas Nevada
United States Suburban Hematology-Oncology Associates Lawrenceville Georgia
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Lebanon Tennessee
United States North Shore Oncology Hematology Associates Libertyville Illinois
United States Little Rock Hematology Oncology Associates Little Rock Arkansas
United States University of Arkansas for Medical Sciences Little Rock Arkansas
United States LLU Faculty Medical Offices Loma Linda California
United States LLU Faculty Meidical Offices Loma Linda California
United States Loma Linda University Medical Center Loma Linda California
United States David Geffen School of Medicine at UCLA Los Angeles California
United States Women's Cancer Center - Community Hospital Los Gatos Los Gatos California
United States Univ. of Louisville, Div. of Gynecologic Oncology Louisville Kentucky
United States Med-Onc/Hem Malone New York
United States Marshfield Clinic Research Foundation Marshfield Wisconsin
United States Saint Joseph's Hospital Marshfield Wisconsin
United States Wisconsin Rapid Cancer Center Marshfield Wisconsin
United States Hillcrest Hospital Cancer Center Mayfield Heights Ohio
United States North Shore Oncology Hematology Associates McHenry Illinois
United States Merrill Cancer Center Merrill Wisconsin
United States OncRx (Pharmacy) Metairie Louisiana
United States Medical Consultants, Ltd. Milwaukee Wisconsin
United States Marshfield Clinc - Lakeland Center Minocqua Wisconsin
United States Marshfield Clinic - Lakeland Center Minocqua Wisconsin
United States Joliet Oncology-Hematology Associates, Ltd. Morris Illinois
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Murfreesboro Tennessee
United States Southwest Cancer Care Murrieta California
United States The Consultant Group Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Nashville Tennessee
United States Jersey Shore University Medical Center Neptune New Jersey
United States Robert Wood Johnson University Hospital New Brunswick New Jersey
United States The Cancer Institute of New Jersey New Brunswick New Jersey
United States Hematology-Oncology Associates of Rockland New City New York
United States Long Island Jewish Medical Center New Hyde Park New York
United States North Shore-Long Island Jewish Health System/Medical Center New Hyde Park New York
United States Hematology and Oncology Specialists, LLC New Orleans Louisiana
United States Ochsner Clinic Foundation New Orleans Louisiana
United States Bellevue Hospital Center New York New York
United States Comprehensive Cancer Center Medical Practice Offices New York New York
United States Memorial Sloan Kettering Cancer Center New York New York
United States New York University Medical Center - Tisch Hospital New York New York
United States NYU School of Medicine New York New York
United States Gyncologic Oncology Associates Newport Beach California
United States Whittingham Cancer Center at Norwalk Hospital Norwalk Connecticut
United States The Union State Bank Cancer Center at Nyack Hospital Nyack New York
United States Kaiser Permanente Oncology Clinical Trials Program Oakland California
United States N. County Oncology Medical Oceanside California
United States OU Medical Center - Everett Tower Oklahoma City Oklahoma
United States OU Physicians' Bldg. Oklahoma City Oklahoma
United States Presbyterian Oklahoma City Oklahoma
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Western Washington Oncology Olympia Washington
United States Western Washington Oncology Olympia Washington
United States Florida Hospital Orlando Florida
United States Gynecologic Oncology Orlando Florida
United States Florida Hospital Memorial Division Ormond Beach Florida
United States Florida Hospital Memorial Division, Cancer Care Center Ormond Beach Florida
United States Palm Beach Cancer Institute Palm Beach Gardens Florida
United States Gynecologic Oncology Associates Pembroke Pines Florida
United States Magee-Womens Hospital Pittsburgh Pennsylvania
United States Hematology/Oncology Associates of Treasure Coast Port St. Lucie Florida
United States Kaiser Permanente Nw, Oncology Research Portland Oregon
United States Oregon Health & Science University Portland Oregon
United States Oregon Health Science University Portland Oregon
United States Southwest Cancer Care Poway California
United States Kaiser Permanente Oncology Clinical Trials Program Redwood City California
United States Diagnostic Radiology Associates Rice Lake Wisconsin
United States Lakeview Medical Center Rice Lake Wisconsin
United States Marshfield Clinic - Indianhead Center Rice Lake Wisconsin
United States Gynecologic-Oncology Rochester New York
United States Kaiser Permanente Oncology Clinical Trials Program Roseville California
United States Women's Cancer Research Foundation, Inc. S. Miami Florida
United States Kaiser Permanente Oncology Clinical Trials Program Sacramento California
United States Medical Oncology Associates-SD San Diego California
United States Sharp Healthcare Clinical Oncology Research San Diego California
United States Sharp Memorial Hospital San Diego California
United States Sharp Rees-Stealy San Diego California
United States Southern California Permanente Medical Group San Diego California
United States Kaiser Permanente Oncology Clinical Trials Program San Francisco California
United States Kaiser Permanente Oncology Clinical Trials Program San Rafael California
United States Kaiser Permanente Oncology Clinical Trials Program Santa Clara California
United States Kaiser Permanente Oncology Clinical Trials Program Santa Rosa California
United States Kaiser Permanente Oncology Clinical Trails Program Santa Teresa California
United States Memorial Health University Medical Center Savannah Georgia
United States Horizon's West Medical Group Scottsbluff Nebraska
United States Community Medical Center Scranton Pennsylvania
United States Mercy Health Partners Scranton Pennsylvania
United States Moses Taylor Hospital Scranton Pennsylvania
United States Viewmont Medical Services Scranton Pennsylvania
United States Western Washington Oncology Shelton Washington
United States Hematology Oncology of the Northern Rockies Sheridan Wyoming
United States LSU Health Sciences Center Shreveport Louisiana
United States Sioux Calley Clinic OBGYN Ltd. Sioux Falls South Dakota
United States Sioux Valley Clinic Clinical Research Center Sioux Falls South Dakota
United States Sioux Valley Clinic Oncology Sioux Falls South Dakota
United States Sioux Valley Hospital - North Center Radiology Sioux Falls South Dakota
United States Hematology Oncology Associates of Illinois (HOAI) Skokie Illinois
United States Midwest Cancer Research Group, Inc. Skokie Illinois
United States The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Smyma Tennessee
United States Suburban Hematology Oncology Snellville Georgia
United States Michiana Hematology Oncology South Bend Indiana
United States Saint Joseph's Regional South Bend Indiana
United States St. Joseph's Regional South Bend Indiana
United States Kaiser Permanente Oncology Clinical Trials Program South San Francisco California
United States Gynecologic Oncology Research and Development Spartanburg South Carolina
United States Gynecology & Oncology Consultants, PC St. Louis Missouri
United States Saint John's Mercy Hospital St. Louis Missouri
United States St. Louis University, Dept. of Ob-Gyn and Women's Health St. Louis Missouri
United States Hematology Oncology, P.C. Stamford Connecticut
United States Saint Michael Hospital Stevens Point Wisconsin
United States Allenmore Hospital - Hematology Oncology Clinic Tacoma Washington
United States MultiCare Health System - Medical Oncology Tacoma Washington
United States Associates in Hematology-Oncology, P.C. Upland Pennsylvania
United States Kaiser Permanente Oncology Clinical Trials Program Vallejo California
United States Kaiser Permanente Oncology Clinial Trials Program Walnut Creek California
United States Wausau Cancer Center Wausau Wisconsin
United States Palm Beach Cancer Institute Wellington Florida
United States Good Samaritan Hospital Medical Center West Islip New York
United States South Bay OB/GYN West Islip New York
United States Palm Beach Cancer Institute West Palm Beach Florida
United States Associates in Women's Health Wichita Kansas
United States Research Support Personnel, LLC Wichita Kansas
United States Piedmont Hematology Oncology Assoc., PA-Salem Research Group Winston-Salem North Carolina
United States Salem Research Group, Inc. Winston-Salem North Carolina
United States Wake Forest University School of Medicine Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Telik

Countries where clinical trial is conducted

United States,  Argentina,  Belgium,  Brazil,  Chile,  Czech Republic,  Germany,  Hungary,  Ireland,  Netherlands,  South Africa,  Spain,  United Kingdom, 

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