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Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]


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

Thank you

Trial Information

Phase III Randomized Study of TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Liposomal Doxorubicin (Doxil) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer [ASSIST-3]


Inclusion Criteria:



- Are a woman 18 years of age or older

- Have histologically or cytologically confirmed epithelial cancer of the
ovary or fallopian tube, or primary peritoneal cancer

- Have platinum refractory or resistant cancer

- Measurable disease according to radiographic RECIST criteria with documented tumor
progression

Exclusion Criteria:

- Had treatment with first-line chemotherapy other than platinum-based regimens
(carboplatin or cisplatin)

- Have clinically significant cardiac disease

- Have any sign of intestinal obstruction interfering with nutrition at the time of
study entry

- Are pregnant or lactating

- Had prior treatment with liposomal doxorubicin for ovarian cancer

- Had prior treatment with TLK286

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Study Objectives

Outcome Description:

To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin

Outcome Time Frame:

Every 8 Weeks

Safety Issue:

Yes

Authority:

United States: Food and Drug Administration

Study ID:

TLK286.3024

NCT ID:

NCT00102973

Start Date:

December 2004

Completion Date:

July 2008

Related Keywords:

  • Ovarian Neoplasms
  • Ovary
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Abington Memorial HospitalAbington, Pennsylvania  19001
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Hoag Memorial Hospital PresbyterianNewport Beach, California  92658
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
Marshfield ClinicMarshfield, Wisconsin  54449
Loma Linda University Medical CenterLoma Linda, California  92354
Memorial Hospital of South BendSouth Bend, Indiana  46601
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Maine Medical CenterPortland, Maine  04102
North Shore University HospitalManhasset, New York  11030
University of Arkansas for Medical SciencesLittle Rock, Arkansas  72205
Boston Medical CenterBoston, Massachusetts  02118
Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Southern California Permanente Medical GroupDowney, California  90242
Dakota Cancer InstituteFargo, North Dakota  58103-4940
Greenville Hospital SystemGreenville, South Carolina  29605
Barrett Cancer CenterCincinnati, Ohio  45267-0502
Long Island Jewish Medical CenterNew Hyde Park, New York  11040
Arlington Cancer CenterArlington, Texas  76012
Duluth ClinicDuluth, Minnesota  55805
Elkhart General HospitalElkhart, Indiana  46515
Hope A Women's Cancer CenterAsheville, North Carolina  28801
Danville Hematology and Oncology, Inc.Danville, Virginia  24541
Massachusetts General HospitalBoston, Massachusetts  02114-2617
Moses Taylor HospitalScranton, Pennsylvania  18510
Miami Valley HospitalDayton, Ohio  45409
Ellis Fischel Cancer CenterColumbia, Missouri  65203
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Palm Beach Cancer InstituteWest Palm Beach, Florida  33401
St. John's Mercy Medical CenterSaint Louis, Missouri  63141
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Southeastern Gynecologic OncologyDecatur, Georgia  30033
Southwest Cancer CarePoway, California  92064
Spartanburg Regional Healthcare SystemSpartanburg, South Carolina  29303
Gynecologic Oncology AssociatesNewport Beach, California  92663
LaPorte HospitalLaPorte, Indiana  46350-0250
Saint Joseph's Regional Medical CenterSouth Bend, Indiana  46634-1935
Saint Louis UniversitySt. Louis, Missouri  63104
Oregon Health & Science UniversityPortland, Oregon  97201
Cancer Care AssociatesTulsa, Oklahoma  74136
Kapiolani Medical Center for Women and ChildrenHonolulu, Hawaii  96826
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Deaconess Billings ClinicBillings, Montana  59107-5100
Parkridge Medical CenterChattanooga, Tennessee  37404
Kaiser Permanente Medical CenterVallejo, California  94589
Texas Cancer AssociatesDallas, Texas  75231
Blumenthal Cancer CenterCharlotte, North Carolina  28203
University Of Cincinnati Medical CenterCincinnati,, Ohio  45267-0589
Alegent Health Immanuel Medical CenterOmaha, Nebraska  68122
California Oncology of the Central ValleyFresno, California  93710
Hematology and Oncology Specialists, LLCNew Orleans, Louisiana  70115
Chattanooga GYN OncologyChattanooga, Tennessee  37403
Carilion GYN Oncology AssociatesRoanoke, Virginia  24014
Bay Area Cancer Research Group, LLCConcord, California  94520
The Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
LSU Health Sciences CenterShreveport, Louisiana  71130-3932
Hematology-Oncology Associates of RocklandNyack, New York  10956
Sharp Rees-StealyLa Mesa, California  91942
LLU Faculty Medical OfficesLoma Linda, California  92354
David Geffen School of Medicine at UCLALos Angeles, California  90095
N. County Oncology MedicalOceanside, California  92056
The Center for Hematology-OncologyBoca Raton, Florida  33486
Florida HospitalOrlando, Florida  32803
Memorial Health University Medical CenterSavannah, Georgia  31404
OncRx (Pharmacy)Metairie, Louisiana  70002
Jersey Shore University Medical CenterNeptune, New Jersey  07754
Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
The Mary Imogene Bassett HospitalCooperstown, New York  13326
Presbyterian Gynecologic OncologyCharlotte, North Carolina  28204
UC Physician's Medical Arts BuildingCincinnati, Ohio  45219
Hematology & Oncology Associates of NEPADunmore, 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 Valley Clinic OncologySioux Falls, South Dakota  57104
Sioux Valley Hospital - North Center RadiologySioux Falls, South Dakota  57104
Covington Multicare - Oncology ClinicCovington, Washington  98042
MultiCare Health System - Medical OncologyTacoma, Washington  98405
Allenmore Hospital - Hematology Oncology ClinicTacoma, Washington  98405
Schwartz Gynecologic OncologyBrightwaters, New York  11718
Kaiser Permanente Northwest RegionPortland, Oregon  97227
The Family Cancer CenterCollierville, Tennessee  38017
Western Washington Oncology, Inc., P.S.Lacey, Washington  98503
Lakeland HospitalSt. Joseph, Michigan  49085
The Toledo HospitalToledo, Ohio  43606
Clinical Trials and Research Associates, Inc.Montebello, California  60460
Diablo Valley Oncology & Hematology Medical Group, Inc.Walnut Creek, California  94598
Sparrow Health SystemLansing, Michigan  48912
Horizons West Medical GroupScottsbluff, Nebraska  69361
Piedmont Hematology Oncology AssociatesWinston Salem, North Carolina  27103
Odyssey ResearchBismarck, North Dakota  58501
Center for Oncology Research and Treatment, PADallas, Texas  75230
Odyssey ResearchScottsbluff, Nebraska  69361
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Citrus Hematology and Oncology CenterInverness, Florida  34452
Florida Wellcare Alliance, LCInverness, Florida  34452
Center for Cancer and Blood Disorders, P. C.Bethesda, Maryland  20817
Oncology Care Medical AssociatesMontebello, California  90640
St. Vincent HospitalIndianapolis, Indiana  46260
Cancer and Blood Disease CenterLecanto, Florida  34461
Arkansas Oncology AssociatesLittle Rock, Arkansas  72205
Little Rock Hematology OncologyLittle Rock, Arkansas  72205
East Bay Oncology/Hematology Medical Associates, Inc.Antioch, California  94509
Marilyn Norton, M.D.Chula Vista, California  91911
Cancer Center Oncology Medical GroupLa Mesa, California  91942
OB/GYN Consult SuiteLos Angeles, California  90095
Bowyer Oncology CenterLos Angeles, California  90095
Beverly Oncology and ImagingMontebello, California  90640
Newport Imaging CenterNewport Beach, California  92660
Sharp Memorial Hospital - Investigational PharmacySan Diego, California  92123
Medical Oncology AssociatesSan Diego, California  92123
Southern Permanente Medical GroupWoodland Hills, California  91367
University of Connecticut Health Center/John Dempsey HospitalFarmington, Connecticut  06030
Citrus Diagnostic CenterCrystal River, Florida  34428
GYN Oncology Associates, Inc.Hollywood, Florida  33021
Citrus Memorial Hospital Radiology Dept.Inverness, Florida  34452
Shands Jacksonville Medical CenterJacksonville, Florida  32209
Gynecology OncologyOrlando, Florida  32804
Florida Hospital Memorial SystemOrmond Beach, Florida  32174
Florida Hospital Memorial Division - Cancer Care CenterOrmond Beach, Florida  32174
Kaiser Permanente HawaiiHonolulu, Hawaii  96819
Joliet Oncology-Hematology Associates, Inc.Flossmoor, Illinois  60422
University Medical Center, Inc. DBA: U of L HospitalLouisville, Kentucky  40202
Hematology and Oncology SpecialistNew Orleans, Louisiana  70006
Maine Medical Center - Brighton CampusPortland, Maine  04102
Maine Medical Center - Scarborough CampusScarborough, Maine  04074
Dana Farber/Partners Cancer Care, Inc.Boston, Massachusetts  02115
Boston Medical Center - Center for Cancer and Blood DisordersBoston, Massachusetts  02118
Perceptive Informatics, Inc.Waltham, Massachusetts  02451
Providence Cancer Institute and HospitalSouthfield, Michigan  48075
The Family Cancer CenterOlive Branch, Mississippi  38654
St. John's Mercy-David C. Pratt Cancer CenterSt. Louis, Missouri  63141
Hematology & Oncology Consultants, PCOmaha, Nebraska  68122
The Women's Center of Western NebraskaScottsbluff, Nebraska  69361
Regional West Medical CenterScottsbluff, Nebraska  69361
Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756
A. Richard Miskoff, DO, PAEdison, New Jersey  08818
JFK Medical CenterEdison, New Jersey  08818
Jsumc Ob/GynWest Long Branch, New Jersey  07764
Gynecologic Oncology & Minimally Invasive SurgeryBabylon, New York  11702
The Union State Bank Cancer CenterNyack, New York  10960
Asheville RadiologyAsheville, North Carolina  28801
Inpatient PharmacyCharlotte, North Carolina  28203
Cancer Care Center - Medcenter One, Inc.Bismarck, North Dakota  58501
Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.Bismarck, North Dakota  58501
Fairview Hospital Moll PavilionCleveland, Ohio  44111
Mid Ohio Onc/Hem (East)Columbus, Ohio  43213
Mid Ohio Onc/Hem (West)Columbus, Ohio  43222
GOPSAColumbus, Ohio  43222
Hillcrest Hospital/Cleveland Clinic Health SystemMayfield Heights, Ohio  44124
ProMedica Health SystemToledo, Ohio  43606
Garth Phibbs, M.D., FACOGToledo, Ohio  43606
Mid Onio Onc/Hem (North)Westerville, Ohio  43081
Advance ImagingDunmore, Pennsylvania  18512
Magee-Womens Hospital of UPMCPittsburgh, Pennsylvania  15213
Roper Hospital-Department of RadiologyCharleston, South Carolina  29401
South Carolina OncologyColumbia, South Carolina  29210
Sioux Valley Clinic OBGYN, Ltd.Sioux Falls, South Dakota  57105
Sioux Valley Clinic - Clinical Research CenterSioux Falls, South Dakota  57104
Baroness Erlander HospitalChattanooga, Tennessee  37403
VCU Health System-Dalton Oncology Clinic, North HospitalRichmond, Virginia  23298
VCU Health System at Stony PointRichmond, Virginia  23235
Western Washington Oncology, Inc., P. S.Centralia, Washington  98531
Gig Harbor Medical OncologyGig Harbor, Washington  98335
Marshfield Clinic - Chippewa Falls CenterChippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart HospitalEau Claire, Wisconsin  54701
St. Michael's HospitalStevens Point, Wisconsin  54481
Marchfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic Weston CenterWeston, Wisconsin  54476