Know Cancer

forgot password

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
Not Enrolling
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

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:


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:



United States: Food and Drug Administration

Study ID:




Start Date:

December 2004

Completion Date:

July 2008

Related Keywords:

  • Ovarian Neoplasms
  • Ovary
  • Neoplasms
  • Ovarian Neoplasms



Abington Memorial Hospital Abington, Pennsylvania  19001
Sinai Hospital of Baltimore Baltimore, Maryland  21225
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
Hoag Memorial Hospital Presbyterian Newport Beach, California  92658
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
Marshfield Clinic Marshfield, Wisconsin  54449
Loma Linda University Medical Center Loma Linda, California  92354
Memorial Hospital of South Bend South Bend, Indiana  46601
James Graham Brown Cancer Center Louisville, Kentucky  40202
Maine Medical Center Portland, Maine  04102
North Shore University Hospital Manhasset, New York  11030
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Boston Medical Center Boston, Massachusetts  02118
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Southern California Permanente Medical Group Downey, California  90242
Dakota Cancer Institute Fargo, North Dakota  58103-4940
Greenville Hospital System Greenville, South Carolina  29605
Barrett Cancer Center Cincinnati, Ohio  45267-0502
Long Island Jewish Medical Center New Hyde Park, New York  11040
Arlington Cancer Center Arlington, Texas  76012
Duluth Clinic Duluth, Minnesota  55805
Elkhart General Hospital Elkhart, Indiana  46515
Hope A Women's Cancer Center Asheville, North Carolina  28801
Danville Hematology and Oncology, Inc. Danville, Virginia  24541
Massachusetts General Hospital Boston, Massachusetts  02114-2617
Moses Taylor Hospital Scranton, Pennsylvania  18510
Miami Valley Hospital Dayton, Ohio  45409
Ellis Fischel Cancer Center Columbia, Missouri  65203
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Marshfield Clinic - Wisconsin Rapids Center Wisconsin Rapids, Wisconsin  54494
Palm Beach Cancer Institute West Palm Beach, Florida  33401
St. John's Mercy Medical Center Saint Louis, Missouri  63141
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Southeastern Gynecologic Oncology Decatur, Georgia  30033
Southwest Cancer Care Poway, California  92064
Spartanburg Regional Healthcare System Spartanburg, South Carolina  29303
Gynecologic Oncology Associates Newport Beach, California  92663
LaPorte Hospital LaPorte, Indiana  46350-0250
Saint Joseph's Regional Medical Center South Bend, Indiana  46634-1935
Saint Louis University St. Louis, Missouri  63104
Oregon Health & Science University Portland, Oregon  97201
Cancer Care Associates Tulsa, Oklahoma  74136
Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
Deaconess Billings Clinic Billings, Montana  59107-5100
Parkridge Medical Center Chattanooga, Tennessee  37404
Kaiser Permanente Medical Center Vallejo, California  94589
Texas Cancer Associates Dallas, Texas  75231
Blumenthal Cancer Center Charlotte, North Carolina  28203
University Of Cincinnati Medical Center Cincinnati,, Ohio  45267-0589
Alegent Health Immanuel Medical Center Omaha, Nebraska  68122
California Oncology of the Central Valley Fresno, California  93710
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
Chattanooga GYN Oncology Chattanooga, Tennessee  37403
Carilion GYN Oncology Associates Roanoke, Virginia  24014
Bay Area Cancer Research Group, LLC Concord, California  94520
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Hematology-Oncology Associates of Rockland Nyack, New York  10956
Sharp Rees-Stealy La Mesa, California  91942
LLU Faculty Medical Offices Loma Linda, California  92354
David Geffen School of Medicine at UCLA Los Angeles, California  90095
N. County Oncology Medical Oceanside, California  92056
The Center for Hematology-Oncology Boca Raton, Florida  33486
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
OncRx (Pharmacy) Metairie, Louisiana  70002
Jersey Shore University Medical Center Neptune, New Jersey  07754
Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
The Mary Imogene Bassett Hospital Cooperstown, New York  13326
Presbyterian Gynecologic Oncology Charlotte, North Carolina  28204
UC Physician's Medical Arts Building Cincinnati, Ohio  45219
Hematology & Oncology Associates of NEPA Dunmore, Pennsylvania  18512
Viewmont Medical Services Scranton, Pennsylvania  18508
Community Medical Center Scranton, Pennsylvania  18510
Mercy Health Partners Scranton, Pennsylvania  18510
Associates in Hematology-Oncology, P.C. Upland, Pennsylvania  19013
Carolina Center of Gynecologic Oncology, PA Charleston, South Carolina  29407
Sioux Valley Clinic Oncology Sioux Falls, South Dakota  57104
Sioux Valley Hospital - North Center Radiology Sioux Falls, South Dakota  57104
Covington Multicare - Oncology Clinic Covington, Washington  98042
MultiCare Health System - Medical Oncology Tacoma, Washington  98405
Allenmore Hospital - Hematology Oncology Clinic Tacoma, Washington  98405
Schwartz Gynecologic Oncology Brightwaters, New York  11718
Kaiser Permanente Northwest Region Portland, Oregon  97227
The Family Cancer Center Collierville, Tennessee  38017
Western Washington Oncology, Inc., P.S. Lacey, Washington  98503
Lakeland Hospital St. Joseph, Michigan  49085
The Toledo Hospital Toledo, Ohio  43606
Clinical Trials and Research Associates, Inc. Montebello, California  60460
Diablo Valley Oncology & Hematology Medical Group, Inc. Walnut Creek, California  94598
Sparrow Health System Lansing, Michigan  48912
Horizons West Medical Group Scottsbluff, Nebraska  69361
Piedmont Hematology Oncology Associates Winston Salem, North Carolina  27103
Odyssey Research Bismarck, North Dakota  58501
Center for Oncology Research and Treatment, PA Dallas, Texas  75230
Odyssey Research Scottsbluff, Nebraska  69361
University of North Carolina at Chapel Hill Chapel Hill, North Carolina  27599
Citrus Hematology and Oncology Center Inverness, Florida  34452
Florida Wellcare Alliance, LC Inverness, Florida  34452
Center for Cancer and Blood Disorders, P. C. Bethesda, Maryland  20817
Oncology Care Medical Associates Montebello, California  90640
St. Vincent Hospital Indianapolis, Indiana  46260
Cancer and Blood Disease Center Lecanto, Florida  34461
Arkansas Oncology Associates Little Rock, Arkansas  72205
Little Rock Hematology Oncology Little 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 Group La Mesa, California  91942
OB/GYN Consult Suite Los Angeles, California  90095
Bowyer Oncology Center Los Angeles, California  90095
Beverly Oncology and Imaging Montebello, California  90640
Newport Imaging Center Newport Beach, California  92660
Sharp Memorial Hospital - Investigational Pharmacy San Diego, California  92123
Medical Oncology Associates San Diego, California  92123
Southern Permanente Medical Group Woodland Hills, California  91367
University of Connecticut Health Center/John Dempsey Hospital Farmington, Connecticut  06030
Citrus Diagnostic Center Crystal River, Florida  34428
GYN Oncology Associates, Inc. Hollywood, Florida  33021
Citrus Memorial Hospital Radiology Dept. Inverness, Florida  34452
Shands Jacksonville Medical Center Jacksonville, Florida  32209
Gynecology Oncology Orlando, Florida  32804
Florida Hospital Memorial System Ormond Beach, Florida  32174
Florida Hospital Memorial Division - Cancer Care Center Ormond Beach, Florida  32174
Kaiser Permanente Hawaii Honolulu, Hawaii  96819
Joliet Oncology-Hematology Associates, Inc. Flossmoor, Illinois  60422
University Medical Center, Inc. DBA: U of L Hospital Louisville, Kentucky  40202
Hematology and Oncology Specialist New Orleans, Louisiana  70006
Maine Medical Center - Brighton Campus Portland, Maine  04102
Maine Medical Center - Scarborough Campus Scarborough, Maine  04074
Dana Farber/Partners Cancer Care, Inc. Boston, Massachusetts  02115
Boston Medical Center - Center for Cancer and Blood Disorders Boston, Massachusetts  02118
Perceptive Informatics, Inc. Waltham, Massachusetts  02451
Providence Cancer Institute and Hospital Southfield, Michigan  48075
The Family Cancer Center Olive Branch, Mississippi  38654
St. John's Mercy-David C. Pratt Cancer Center St. Louis, Missouri  63141
Hematology & Oncology Consultants, PC Omaha, Nebraska  68122
The Women's Center of Western Nebraska Scottsbluff, Nebraska  69361
Regional West Medical Center Scottsbluff, Nebraska  69361
Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756
A. Richard Miskoff, DO, PA Edison, New Jersey  08818
JFK Medical Center Edison, New Jersey  08818
Jsumc Ob/Gyn West Long Branch, New Jersey  07764
Gynecologic Oncology & Minimally Invasive Surgery Babylon, New York  11702
The Union State Bank Cancer Center Nyack, New York  10960
Asheville Radiology Asheville, North Carolina  28801
Inpatient Pharmacy Charlotte, 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 Pavilion Cleveland, Ohio  44111
Mid Ohio Onc/Hem (East) Columbus, Ohio  43213
Mid Ohio Onc/Hem (West) Columbus, Ohio  43222
GOPSA Columbus, Ohio  43222
Hillcrest Hospital/Cleveland Clinic Health System Mayfield Heights, Ohio  44124
ProMedica Health System Toledo, Ohio  43606
Garth Phibbs, M.D., FACOG Toledo, Ohio  43606
Mid Onio Onc/Hem (North) Westerville, Ohio  43081
Advance Imaging Dunmore, Pennsylvania  18512
Magee-Womens Hospital of UPMC Pittsburgh, Pennsylvania  15213
Roper Hospital-Department of Radiology Charleston, South Carolina  29401
South Carolina Oncology Columbia, South Carolina  29210
Sioux Valley Clinic OBGYN, Ltd. Sioux Falls, South Dakota  57105
Sioux Valley Clinic - Clinical Research Center Sioux Falls, South Dakota  57104
Baroness Erlander Hospital Chattanooga, Tennessee  37403
VCU Health System-Dalton Oncology Clinic, North Hospital Richmond, Virginia  23298
VCU Health System at Stony Point Richmond, Virginia  23235
Western Washington Oncology, Inc., P. S. Centralia, Washington  98531
Gig Harbor Medical Oncology Gig Harbor, Washington  98335
Marshfield Clinic - Chippewa Falls Center Chippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital Eau Claire, Wisconsin  54701
St. Michael's Hospital Stevens Point, Wisconsin  54481
Marchfield Clinic - Wausau Center Wausau, Wisconsin  54401
Marshfield Clinic Weston Center Weston, Wisconsin  54476