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Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Phase 3
18 Years
Not Enrolling
Ovarian Neoplasms

Thank you

Trial Information

Phase 3 Randomized Study of TLK286 (Telcyta®) in Combination With Liposomal Doxorubicin (Doxil/Caelyx)Versus Liposomal Doxorubicin (Doxil/Caelyx) as Second-Line Therapy in Platinum Refractory or Resistant Ovarian Cancer (ASSIST-5)

Inclusion Criteria:

- Are a woman 18 years of age or older

- Have histologically or cytologically confirmed epithelial cancer or primary
peritoneal cancer

- Have platinum refractory or resistant cancer

- Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

- Had treatment with first-line chemotherapy other than a platinum-containing regimen

- Have clinically significant cardiac disease

- Have any sign of intestinal obstruction interfering with nutrition

- Are pregnant or lactating

- Had prior treatment with liposomal doxorubicin

- Had prior treatment with Telcyta

Type of Study:


Study Design:

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

Outcome Measure:

To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxirubicin as compared with the active control arm liposomal doxorubicin

Outcome Time Frame:

Once 244 planned pts. received at least 2 cycles of study treatment(s)

Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

May 2006

Completion Date:

December 2008

Related Keywords:

  • Ovarian Neoplasms
  • Ovary
  • Neoplasms
  • Ovarian Neoplasms



Abington Memorial Hospital Abington, Pennsylvania  19001
North Shore University Hospital Manhasset, New York  11030
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Florida Hospital Cancer Institute Orlando, Florida  32804
Carolinas Medical Center Charlotte, North Carolina  28232-2861
Southern California Permanente Medical Group Downey, California  90242
Central Baptist Hospital Lexington, Kentucky  40503
Long Island Jewish Medical Center New Hyde Park, New York  11040
Arlington Cancer Center Arlington, Texas  76012
Hope A Women's Cancer Center Asheville, North Carolina  28801
Presbyterian Hospital Charlotte, North Carolina  28233-3549
Southwest Cancer Care Poway, California  92064
Oregon Health & Science University Portland, Oregon  97201
South Carolina Oncology Associates Columbia, South Carolina  29201
Hematology Oncology Services of Arkansas Little Rock, Arkansas  72205
Blumenthal Cancer Center Charlotte, North Carolina  28203
California Oncology of the Central Valley Fresno, California  93710
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
St. Vincent Gynecologic Oncology Indianapolis, Indiana  46260
Carilion GYN Oncology Associates Roanoke, Virginia  24014
Bay Area Cancer Research Group, LLC Concord, California  94520
Danville Hematology & Oncology, Inc. Danville, Virginia  24541
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Florida Hospital Orlando, Florida  32803
Memorial Health University Medical Center Savannah, Georgia  31404
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
Horizon's West Medical Group Scottsbluff, Nebraska  69361
The Mary Imogene Bassett Hospital Cooperstown, New York  13326
Hematology & Oncology Associates of NEPA Dunmore, Pennsylvania  18512
The Toledo Hospital Toledo, Ohio  43606
East Bay Medical Oncology/Hematology Medical Associates, Inc. Antioch, California  94509
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Piedmont Hematology Oncology Associates Winston Salem, North Carolina  27103
Desert Oasis Cancer Center Casa Grande, Arizona  85222
Shands Jacksonville Medical Center Jacksonville, Florida  32209
The Women's Center of Western Nebraska Scottsbluff, Nebraska  69361
Garth Phibbs, M.D., FACOG Toledo, Ohio  43606
Desert Hematology Oncology Medical Group Rancho Mirage, California  92270
Hematology & Oncology Consultants P.C. Omaha, Nebraska  68122
Arch Medical Services St. Louis, Missouri  63141
Monter Cancer Center Lake Success, New York  11042
Joliet Oncology-Hematology Associates Joliet, Illinois  60435
Kaiser Permanente Moanalua Medical Center Honolulu, Hawaii  96819
East Bay Medical Oncology/Hematology Medical Associates Concord, California  94520
Women's Cancer Research Foundation Newport Beach, California  92663
East Bay Medical Oncoogy/Hematology Medical Associates, Inc. San Leandro, California  94578
Gynecologic Oncology Associates, Inc Hollywood, Florida  33020
University of Florida College of Medicine-Jacksonville Jacksonville, Florida  32209
Flossmoor Cancer Care (JOHA DBA) Flossmoor, Illinois  60422
Kankakee Cancer Center (JOHA DBA) Kankakee, Illinois  60901
Schwaartz Gynecologic Oncology, PLLC Babylon, New York  11702
Piedmont Hematology Oncology Associates-Lexington Satellite Lexington, North Carolina  27292
Dakota Cancer Institute/Dakota Clinic Ltd. Fargo, North Dakota  58103
Gynecologic Oncology & Pelvic Surgery Associates Columbus, Ohio  43222
Kaiser Permanente NW, Oncology/Hematology Portland, Oregon  97227
Magee Women's Hospital of UPMC Pittsburgh, Pennsylvania  15213
Associates in Hematolog-Oncology, P.C. Upland, Pennsylvania  19013
Carolina Center of Gynecologic Oncology Charleston, South Carolina  29407
Palmetto Health Alliance-Richland Columbia, South Carolina  29210