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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)]


Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms

Thank you

Trial Information

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)]

Inclusion Criteria


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

Type of Study:

Interventional

Study Design:

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

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.3017

NCT ID:

NCT00057720

Start Date:

June 2003

Completion Date:

December 2006

Related Keywords:

  • Ovarian Neoplasms
  • ovary
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

University of IowaIowa City, Iowa  52242
Memorial Sloan Kettering Cancer CenterNew York, New York  10021
University of Iowa Hospitals and ClinicsIowa City, Iowa  52242
St. Vincent Hospital and Health Care CenterIndianapolis, Indiana  46260
Sparrow Regional Cancer CenterLansing, Michigan  48912-1811
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Loma Linda University Medical CenterLoma Linda, California  92354
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Ochsner Clinic FoundationNew Orleans, Louisiana  70121
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Southern California Permanente Medical GroupDowney, California  90242
Dakota Cancer InstituteFargo, North Dakota  58103-4940
MetroHealth Medical CenterCleveland, Ohio  44109
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Arlington Cancer CenterArlington, Texas  76012
Oncology/Hematology Care, Inc.Cincinnati, Ohio  45219
Elkhart General HospitalElkhart, Indiana  46515
Nevada Cancer CenterLas Vegas, Nevada  89109
Danville Hematology and Oncology, Inc.Danville, Virginia  24541
North Shore Oncology Hematology AssociatesLibertyville, Illinois  60048
Midwest Cancer Research Group, Inc.Skokie, Illinois  60077
Magee-Womens HospitalPittsburgh, Pennsylvania  15213-3180
Moses Taylor HospitalScranton, Pennsylvania  18510
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Saint Joseph's HospitalMarshfield, Wisconsin  54449
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
Sharp Memorial HospitalSan Diego, California  92123
Southwest Cancer CarePoway, California  92064
Hematology Oncology, P.C.Stamford, Connecticut  06902
St. Joseph Mercy HospitalPontiac, Michigan  48341-2985
Metro Health Medical CenterCleveland, Ohio  44109
Gynecologic Oncology AssociatesNewport Beach, California  92663
Whittingham Cancer Center at Norwalk HospitalNorwalk, Connecticut  06856
Oregon Health & Science UniversityPortland, Oregon  97201
South Carolina Oncology Associates, PAColumbia, South Carolina  29210
Indiana Cancer PavilionIndianapolis, Indiana  46202
Deaconess Billings ClinicBillings, Montana  59107-5100
MacNeal Cancer CenterBerwyn, Illinois  60402
Western Washington OncologyOlympia, Washington  98502
Salem Research Group, Inc.Winston Salem, North Carolina  27103
Straub Clinic and HospitalHonolulu, Hawaii  96813
Mid Dakota ClinicBismarck, North Dakota  58501
Indiana University Medical CenterIndianapolis, Indiana  46202
Texas Cancer AssociatesDallas, Texas  75231
Blumenthal Cancer CenterCharlotte, North Carolina  28203
Odyssey Research ServicesBismarck, North Dakota  58501
California Oncology of the Central ValleyFresno, California  93710
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
St. Vincent Gynecologic OncologyIndianapolis, Indiana  46260
Gynecologic Oncology Research and DevelopmentGreenville, South Carolina  29601
Texas Oncology, PADallas, Texas  75246-2006
Decatur Memorial HospitalDecatur, Illinois  62526
Hematology Oncology Centers of the Northern RockiesBillings, Montana  59101
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Wake Forest University School of MedicineWinston-Salem, North Carolina  27157-1023
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Hematology-Oncology Associates of RocklandNyack, New York  10956
Little Rock Hematology Oncology AssociatesLittle Rock, Arkansas  72205
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Marilyn Norton, M. D.Chula Vista, California  91911
Rosalba Rodriguez, M. D.Chula Vista, California  91911
Bay Area Research Cancer GroupConcord, California  94520
Kaiser Permanente Oncology Clinical Trials ProgramHayward, California  94545
Sharp Rees-StealyLa Mesa, California  91942
Grossmont HospitalLa Mesa, California  91942
LLU Faculty Medical OfficesLoma Linda, California  92354
LLU Faculty Meidical OfficesLoma Linda, California  92354
David Geffen School of Medicine at UCLALos Angeles, California  90095
Women's Cancer Center - Community Hospital Los GatosLos Gatos, California  95032
Gyncologic Oncology AssociatesNewport Beach, California  92663
N. County Oncology MedicalOceanside, California  92056
Sharp Healthcare Clinical Oncology ResearchSan Diego, California  92123
Medical Oncology Associates-SDSan Diego, California  92123
Kaiser Permanente Oncology Clinical Trails ProgramSanta Teresa, California  95119
Kaiser Permanente Oncology Clinial Trials ProgramWalnut Creek, California  94596
The Center for Hematology-OncologyBoca Raton, Florida  33486
Sheridan Clinical Research, Inc.Hollywood, Florida  33021
Memorial Regional HospitalHollywood, Florida  33021
University of Florida Health Science Center/JacksonvilleJacksonville, Florida  32209
Florida HospitalOrlando, Florida  32803
Gynecologic OncologyOrlando, Florida  32804
Florida Hospital Memorial Division, Cancer Care CenterOrmond Beach, Florida  32174
Florida Hospital Memorial DivisionOrmond Beach, Florida  32174
Gynecologic Oncology AssociatesPembroke Pines, Florida  33028
Hematology/Oncology Associates of Treasure CoastPort St. Lucie, Florida  34952
Women's Cancer Research Foundation, Inc.S. Miami, Florida  33143
Suburban Hematology OncologyDuluth, Georgia  30096
Suburban Hematology-Oncology AssociatesLawrenceville, Georgia  30045
Memorial Health University Medical CenterSavannah, Georgia  31404
Univ. of Hawaii, Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Kaiser Permanente - Moanalua Medical CenterHonolulu, Hawaii  96819
Hematology Oncology Associates of Illinois (HOAI)Chicago, Illinois  60657
Swedish Covenant Cancer CenterChicago, Illinois  60625
Cancer Care Specialists of Central ILDecatur, Illinois  62526
Cancer Care Specialists of Central IL-Crossroads Cancer Care CenterEffingham, Illinois  62401
Joliet Oncology-Hematology Associates, Ltd.Flossmoor, Illinois  60422
North Shore Oncology Hematology Associates - Deerpath Medical AssociatesLake Forest, Illinois  60045
Michiana Hematology OncologyElkhart, Indiana  46514
St. Vincent Hospital and Helath Care CenterIndianapolis, Indiana  46260
St. Joseph's RegionalSouth Bend, Indiana  46617
Saint Joseph's RegionalSouth Bend, Indiana  46634
Associates in Women's HealthWichita, Kansas  67214
Research Support Personnel, LLCWichita, Kansas  67208
Oncology/Hematology Care, Inc.Crestview, Kentucky  41017
Univ. of Louisville, Div. of Gynecologic OncologyLouisville, Kentucky  40202
OncRx (Pharmacy)Metairie, Louisiana  70002
Sinai Cancer InstituteBaltimore, Maryland  21205
Center for Cancer and Blood DisordersBethesda, Maryland  20817
St. Elizabeth's Med. Ctr.Boston, Massachusetts  02135
St. Mary's Duluth ClinicDuluth, Minnesota  55805
Gynecology & Oncology Consultants, PCSt. Louis, Missouri  63141
St. Louis University, Dept. of Ob-Gyn and Women's HealthSt. Louis, Missouri  63117
Saint John's Mercy HospitalSt. Louis, Missouri  63141
Hematology & Oncology Centers Northern RockiesBillings, Montana  59101
Horizon's West Medical GroupScottsbluff, Nebraska  69361
Jersey Shore University Medical CenterNeptune, New Jersey  07754
Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
UNM Cancer Research and Treatment CenterAlbuquerque, New Mexico  87131
Benjamin Schwartz, M.D.Babylon, New York  11702
The Mary Imogene Bassett HospitalCooperstown, New York  13326
Med-Onc/HemMalone, New York  12953
North Shore-Long Island Jewish Health System/Medical CenterNew Hyde Park, New York  11040
NYU School of MedicineNew York, New York  10016
Comprehensive Cancer Center Medical Practice OfficesNew York, New York  10016
New York University Medical Center - Tisch HospitalNew York, New York  10016
Bellevue Hospital CenterNew York, New York  10016
The Union State Bank Cancer Center at Nyack HospitalNyack, New York  10960
Gynecologic-OncologyRochester, New York  14620
South Bay OB/GYNWest Islip, New York  11795
Good Samaritan Hospital Medical CenterWest Islip, New York  11795
Presbyterian Gynecologic OncologyCharlotte, North Carolina  28204
Presbyterian Hospital Center for Cancer ResearchCharlotte, North Carolina  28204
Piedmont Hematology Oncology Assoc., PA-Salem Research GroupWinston-Salem, North Carolina  27103
University HospitalCincinnati, Ohio  45219
UC Physician's Medical Arts Bldg.Cincinnati, Ohio  45219
UC Physician's Medical Arts BuildingCincinnati, Ohio  45219
Mid-Ohio Oncology Hematology St. Anne'sColumbus, Ohio  43081
Mid Ohio Oncology HematologyColumbus, Ohio  43213
Mount Carmel HealthColumbus, Ohio  43222
Mid-Ohio Oncology HematologyColumbus, Ohio  43213
Gynecologic OncologyColumbus, Ohio  43222
Wright State Univ. School of MedicineDayton, Ohio  45409
Hillcrest Hospital Cancer CenterMayfield Heights, Ohio  44124
OU Medical Center - Everett TowerOklahoma City, Oklahoma  73104
PresbyterianOklahoma City, Oklahoma  73104
OU Physicians' Bldg.Oklahoma City, Oklahoma  73104
Oregon Health Science UniversityPortland, Oregon  97239
Kaiser Permanente Nw, Oncology ResearchPortland, Oregon  97227
Abington Mem. Hospita/Rosenfield Cancer CenterAbington, Pennsylvania  19001
Hematology & Oncology Associates of NEPADunmore, Pennsylvania  18512
Advanced ImagingDunmore, Pennsylvania  18512
Viewmont Medical ServicesScranton, Pennsylvania  18508
Community Medical CenterScranton, Pennsylvania  18510
Mercy Health PartnersScranton, Pennsylvania  18510
Associates in Hematology-Oncology, P.C.Upland, Pennsylvania  19013
Carolina Center of Gynecologic Oncology, PACharleston, South Carolina  29407
Sioux Calley Clinic OBGYN Ltd.Sioux Falls, South Dakota  57105
Sioux Valley Clinic Clinical Research CenterSioux Falls, South Dakota  57104
Sioux Valley Clinic OncologySioux Falls, South Dakota  57104
Sioux Valley Hospital - North Center RadiologySioux Falls, South Dakota  57104
Chattanooga Oncology & Hematology Associates, P.C.Chattanooga, Tennessee  37404
Memorial HospitalChattanooga, Tennessee  37404
The Consultant GroupFranklin, Tennessee  37067
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLCGallatin, Tennessee  37066
Saint Mary's Health System, Inc.Knoxville, Tennessee  37917
Fort Sanders Parkwest Medical CenterKnoxville, Tennessee  37923
Hall and Martin, M.D.'s, P.C.Knoxville, Tennessee  37920
Amarillo Cancer CenterAmarillo, Texas  79106
Dallas Oncology ConsultantsDallas, Texas  75201
Southwest Fort Worth Cancer CenterFort Worth, Texas  76132
Univ. of TX, MD Anderson Cancer CenterHouston, Texas  77030
Covington Multicare - Oncology ClinicCovington, Washington  98042
MultiCare Health System - Medical OncologyTacoma, Washington  98405
Allenmore Hospital - Hematology Oncology ClinicTacoma, Washington  98405
Chippewa Falls Cancer CenterChippewa Falls, Wisconsin  54729
Regional Cancer CenterEau Claire, Wisconsin  54701
Wisconsin Rapid Cancer CenterMarshfield, Wisconsin  54494
Merrill Cancer CenterMerrill, Wisconsin  54452
Medical Consultants, Ltd.Milwaukee, Wisconsin  53215
Marshfield Clinc - Lakeland CenterMinocqua, Wisconsin  54548
Diagnostic Radiology AssociatesRice Lake, Wisconsin  54868
Lakeview Medical CenterRice Lake, Wisconsin  54868
Saint Michael HospitalStevens Point, Wisconsin  54481
Wausau Cancer CenterWausau, Wisconsin  54401
Hematology Oncology Centers of the Northern RockiesCody, Wyoming  82414
Hematology Oncology of the Northern RockiesSheridan, Wyoming  82801