Know Cancer

forgot password

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
Not Enrolling
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

- Pregnant or lactating women

Type of Study:


Study Design:

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


United States: Food and Drug Administration

Study ID:




Start Date:

June 2003

Completion Date:

December 2006

Related Keywords:

  • Ovarian Neoplasms
  • ovary
  • Neoplasms
  • Ovarian Neoplasms



University of Iowa Iowa City, Iowa  52242
Memorial Sloan Kettering Cancer Center New York, New York  10021
University of Iowa Hospitals and Clinics Iowa City, Iowa  52242
St. Vincent Hospital and Health Care Center Indianapolis, Indiana  46260
Sparrow Regional Cancer Center Lansing, Michigan  48912-1811
Marshfield Clinic - Indianhead Center Rice Lake, Wisconsin  54868
Loma Linda University Medical Center Loma Linda, California  92354
University of Arkansas for Medical Sciences Little Rock, Arkansas  72205
Ochsner Clinic Foundation New Orleans, Louisiana  70121
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Southern California Permanente Medical Group Downey, California  90242
Dakota Cancer Institute Fargo, North Dakota  58103-4940
MetroHealth Medical Center Cleveland, Ohio  44109
Barrett Cancer Center Cincinnati, Ohio  45267-0502
Long Island Jewish Medical Center New Hyde Park, New York  11040
Arlington Cancer Center Arlington, Texas  76012
Oncology/Hematology Care, Inc. Cincinnati, Ohio  45219
Elkhart General Hospital Elkhart, Indiana  46515
Nevada Cancer Center Las Vegas, Nevada  89109
Danville Hematology and Oncology, Inc. Danville, Virginia  24541
North Shore Oncology Hematology Associates Libertyville, Illinois  60048
Midwest Cancer Research Group, Inc. Skokie, Illinois  60077
Magee-Womens Hospital Pittsburgh, Pennsylvania  15213-3180
Moses Taylor Hospital Scranton, Pennsylvania  18510
Ellis Fischel Cancer Center Columbia, Missouri  65203
Saint Joseph's Hospital Marshfield, Wisconsin  54449
Marshfield Clinic - Lakeland Center Minocqua, Wisconsin  54548
Palm Beach Cancer Institute West Palm Beach, Florida  33401
Sharp Memorial Hospital San Diego, California  92123
Southwest Cancer Care Poway, California  92064
Hematology Oncology, P.C. Stamford, Connecticut  06902
St. Joseph Mercy Hospital Pontiac, Michigan  48341-2985
Metro Health Medical Center Cleveland, Ohio  44109
Gynecologic Oncology Associates Newport Beach, California  92663
Whittingham Cancer Center at Norwalk Hospital Norwalk, Connecticut  06856
Oregon Health & Science University Portland, Oregon  97201
South Carolina Oncology Associates, PA Columbia, South Carolina  29210
Indiana Cancer Pavilion Indianapolis, Indiana  46202
Deaconess Billings Clinic Billings, Montana  59107-5100
MacNeal Cancer Center Berwyn, Illinois  60402
Western Washington Oncology Olympia, Washington  98502
Salem Research Group, Inc. Winston Salem, North Carolina  27103
Straub Clinic and Hospital Honolulu, Hawaii  96813
Mid Dakota Clinic Bismarck, North Dakota  58501
Indiana University Medical Center Indianapolis, Indiana  46202
Texas Cancer Associates Dallas, Texas  75231
Blumenthal Cancer Center Charlotte, North Carolina  28203
Odyssey Research Services Bismarck, North Dakota  58501
California Oncology of the Central Valley Fresno, California  93710
Hematology and Oncology Specialists, LLC New Orleans, Louisiana  70115
Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
St. Vincent Gynecologic Oncology Indianapolis, Indiana  46260
Gynecologic Oncology Research and Development Greenville, South Carolina  29601
Texas Oncology, PA Dallas, Texas  75246-2006
Decatur Memorial Hospital Decatur, Illinois  62526
Hematology Oncology Centers of the Northern Rockies Billings, Montana  59101
The Cancer Institute of New Jersey New Brunswick, New Jersey  08901
Wake Forest University School of Medicine Winston-Salem, North Carolina  27157-1023
LSU Health Sciences Center Shreveport, Louisiana  71130-3932
Hematology-Oncology Associates of Rockland Nyack, New York  10956
Little Rock Hematology Oncology Associates Little Rock, Arkansas  72205
Providence Saint Joseph Medical Center Burbank, California  91505-4866
Marilyn Norton, M. D. Chula Vista, California  91911
Rosalba Rodriguez, M. D. Chula Vista, California  91911
Bay Area Research Cancer Group Concord, California  94520
Kaiser Permanente Oncology Clinical Trials Program Hayward, California  94545
Sharp Rees-Stealy La Mesa, California  91942
Grossmont Hospital La Mesa, California  91942
LLU Faculty Medical Offices Loma Linda, California  92354
LLU Faculty Meidical Offices Loma Linda, California  92354
David Geffen School of Medicine at UCLA Los Angeles, California  90095
Women's Cancer Center - Community Hospital Los Gatos Los Gatos, California  95032
Gyncologic Oncology Associates Newport Beach, California  92663
N. County Oncology Medical Oceanside, California  92056
Sharp Healthcare Clinical Oncology Research San Diego, California  92123
Medical Oncology Associates-SD San Diego, California  92123
Kaiser Permanente Oncology Clinical Trails Program Santa Teresa, California  95119
Kaiser Permanente Oncology Clinial Trials Program Walnut Creek, California  94596
The Center for Hematology-Oncology Boca Raton, Florida  33486
Sheridan Clinical Research, Inc. Hollywood, Florida  33021
Memorial Regional Hospital Hollywood, Florida  33021
University of Florida Health Science Center/Jacksonville Jacksonville, Florida  32209
Florida Hospital Orlando, Florida  32803
Gynecologic Oncology Orlando, Florida  32804
Florida Hospital Memorial Division, Cancer Care Center Ormond Beach, Florida  32174
Florida Hospital Memorial Division Ormond Beach, Florida  32174
Gynecologic Oncology Associates Pembroke Pines, Florida  33028
Hematology/Oncology Associates of Treasure Coast Port St. Lucie, Florida  34952
Women's Cancer Research Foundation, Inc. S. Miami, Florida  33143
Suburban Hematology Oncology Duluth, Georgia  30096
Suburban Hematology-Oncology Associates Lawrenceville, Georgia  30045
Memorial Health University Medical Center Savannah, Georgia  31404
Univ. of Hawaii, Kapiolani Medical Center for Women and Children Honolulu, Hawaii  96826
Kaiser Permanente - Moanalua Medical Center Honolulu, Hawaii  96819
Hematology Oncology Associates of Illinois (HOAI) Chicago, Illinois  60657
Swedish Covenant Cancer Center Chicago, Illinois  60625
Cancer Care Specialists of Central IL Decatur, Illinois  62526
Cancer Care Specialists of Central IL-Crossroads Cancer Care Center Effingham, Illinois  62401
Joliet Oncology-Hematology Associates, Ltd. Flossmoor, Illinois  60422
North Shore Oncology Hematology Associates - Deerpath Medical Associates Lake Forest, Illinois  60045
Michiana Hematology Oncology Elkhart, Indiana  46514
St. Vincent Hospital and Helath Care Center Indianapolis, Indiana  46260
St. Joseph's Regional South Bend, Indiana  46617
Saint Joseph's Regional South Bend, Indiana  46634
Associates in Women's Health Wichita, Kansas  67214
Research Support Personnel, LLC Wichita, Kansas  67208
Oncology/Hematology Care, Inc. Crestview, Kentucky  41017
Univ. of Louisville, Div. of Gynecologic Oncology Louisville, Kentucky  40202
OncRx (Pharmacy) Metairie, Louisiana  70002
Sinai Cancer Institute Baltimore, Maryland  21205
Center for Cancer and Blood Disorders Bethesda, Maryland  20817
St. Elizabeth's Med. Ctr. Boston, Massachusetts  02135
St. Mary's Duluth Clinic Duluth, Minnesota  55805
Gynecology & Oncology Consultants, PC St. Louis, Missouri  63141
St. Louis University, Dept. of Ob-Gyn and Women's Health St. Louis, Missouri  63117
Saint John's Mercy Hospital St. Louis, Missouri  63141
Hematology & Oncology Centers Northern Rockies Billings, Montana  59101
Horizon's West Medical Group Scottsbluff, Nebraska  69361
Jersey Shore University Medical Center Neptune, New Jersey  07754
Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
UNM Cancer Research and Treatment Center Albuquerque, New Mexico  87131
Benjamin Schwartz, M.D. Babylon, New York  11702
The Mary Imogene Bassett Hospital Cooperstown, New York  13326
Med-Onc/Hem Malone, New York  12953
North Shore-Long Island Jewish Health System/Medical Center New Hyde Park, New York  11040
NYU School of Medicine New York, New York  10016
Comprehensive Cancer Center Medical Practice Offices New York, New York  10016
New York University Medical Center - Tisch Hospital New York, New York  10016
Bellevue Hospital Center New York, New York  10016
The Union State Bank Cancer Center at Nyack Hospital Nyack, New York  10960
Gynecologic-Oncology Rochester, New York  14620
South Bay OB/GYN West Islip, New York  11795
Good Samaritan Hospital Medical Center West Islip, New York  11795
Presbyterian Gynecologic Oncology Charlotte, North Carolina  28204
Presbyterian Hospital Center for Cancer Research Charlotte, North Carolina  28204
Piedmont Hematology Oncology Assoc., PA-Salem Research Group Winston-Salem, North Carolina  27103
University Hospital Cincinnati, Ohio  45219
UC Physician's Medical Arts Bldg. Cincinnati, Ohio  45219
UC Physician's Medical Arts Building Cincinnati, Ohio  45219
Mid-Ohio Oncology Hematology St. Anne's Columbus, Ohio  43081
Mid Ohio Oncology Hematology Columbus, Ohio  43213
Mount Carmel Health Columbus, Ohio  43222
Mid-Ohio Oncology Hematology Columbus, Ohio  43213
Gynecologic Oncology Columbus, Ohio  43222
Wright State Univ. School of Medicine Dayton, Ohio  45409
Hillcrest Hospital Cancer Center Mayfield Heights, Ohio  44124
OU Medical Center - Everett Tower Oklahoma City, Oklahoma  73104
Presbyterian Oklahoma City, Oklahoma  73104
OU Physicians' Bldg. Oklahoma City, Oklahoma  73104
Oregon Health Science University Portland, Oregon  97239
Kaiser Permanente Nw, Oncology Research Portland, Oregon  97227
Abington Mem. Hospita/Rosenfield Cancer Center Abington, Pennsylvania  19001
Hematology & Oncology Associates of NEPA Dunmore, Pennsylvania  18512
Advanced Imaging 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 Calley Clinic OBGYN Ltd. Sioux Falls, South Dakota  57105
Sioux Valley Clinic Clinical Research Center Sioux Falls, South Dakota  57104
Sioux Valley Clinic Oncology Sioux Falls, South Dakota  57104
Sioux Valley Hospital - North Center Radiology Sioux Falls, South Dakota  57104
Chattanooga Oncology & Hematology Associates, P.C. Chattanooga, Tennessee  37404
Memorial Hospital Chattanooga, Tennessee  37404
The Consultant Group Franklin, Tennessee  37067
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC Gallatin, Tennessee  37066
Saint Mary's Health System, Inc. Knoxville, Tennessee  37917
Fort Sanders Parkwest Medical Center Knoxville, Tennessee  37923
Hall and Martin, M.D.'s, P.C. Knoxville, Tennessee  37920
Amarillo Cancer Center Amarillo, Texas  79106
Dallas Oncology Consultants Dallas, Texas  75201
Southwest Fort Worth Cancer Center Fort Worth, Texas  76132
Univ. of TX, MD Anderson Cancer Center Houston, Texas  77030
Covington Multicare - Oncology Clinic Covington, Washington  98042
MultiCare Health System - Medical Oncology Tacoma, Washington  98405
Allenmore Hospital - Hematology Oncology Clinic Tacoma, Washington  98405
Chippewa Falls Cancer Center Chippewa Falls, Wisconsin  54729
Regional Cancer Center Eau Claire, Wisconsin  54701
Wisconsin Rapid Cancer Center Marshfield, Wisconsin  54494
Merrill Cancer Center Merrill, Wisconsin  54452
Medical Consultants, Ltd. Milwaukee, Wisconsin  53215
Marshfield Clinc - Lakeland Center Minocqua, Wisconsin  54548
Diagnostic Radiology Associates Rice Lake, Wisconsin  54868
Lakeview Medical Center Rice Lake, Wisconsin  54868
Saint Michael Hospital Stevens Point, Wisconsin  54481
Wausau Cancer Center Wausau, Wisconsin  54401
Hematology Oncology Centers of the Northern Rockies Cody, Wyoming  82414
Hematology Oncology of the Northern Rockies Sheridan, Wyoming  82801