TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
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]
1 other identifier
interventional
244
1 country
222
Brief Summary
The purpose of this research study is to determine if TLK286 given in combination with carboplatin is more effective than liposomal doxorubicin in treating women who have recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer, that is refractory or resistant to platinum chemotherapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Dec 2004
Typical duration for phase_3
222 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2004
CompletedFirst Submitted
Initial submission to the registry
February 4, 2005
CompletedFirst Posted
Study publicly available on registry
February 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2008
CompletedMay 31, 2012
June 1, 2006
3.6 years
February 4, 2005
May 30, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Study Objectives
To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
Every 8 Weeks
Study Arms (2)
TLK286 in Combination with Carboplatin
EXPERIMENTALDoxorubisin HCl Liposome Injection
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Teliklead
Study Sites (222)
Little Rock Hematology Oncology
Little Rock, Arkansas, 72117, United States
Arkansas Oncology Associates
Little Rock, Arkansas, 72205, United States
Little Rock Hematology Oncology
Little Rock, Arkansas, 72205, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Arkansas Oncology Associates
Little Rock, Arkansas, 72207, United States
Southern California Permanente Medical Group
Anaheim, California, 92807, United States
East Bay Oncology/Hematology Medical Associates, Inc.
Antioch, California, 94509, United States
Southern California Permanente Medical Group
Baldwin Park, California, 91706, United States
Southern California Permanente Medical Group
Bellflower, California, 90706, United States
Marilyn Norton, M.D.
Chula Vista, California, 91911, United States
Bay Area Cancer Research Group, LLC
Concord, California, 94520, United States
East Bay Oncology/Hematology Medical Associates, Inc.
Concord, California, 94520, United States
Southwest Cancer Care
Escondido, California, 92025, United States
Southern California Permanente Medical Group
Fontana, California, 92335, United States
California Oncology of the Central Valley
Fresno, California, 93710, United States
Southern California Permanente Medical Group
Harbor City, California, 90710, United States
Kaiser Permanente Medical Center
Hayward, California, 94545, United States
Gynecologic Oncology Associates
La Jolla, California, 92037, United States
Cancer Center Oncology Medical Group
La Mesa, California, 91942, United States
LLU Faculty Medical Offices
Loma Linda, California, 92354, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Southern California Permanente Medical Group
Los Angeles, California, 90027, United States
Southern California Permanente Medical Group
Los Angeles, California, 90034, United States
Bowyer Oncology Center
Los Angeles, California, 90095, United States
David Geffen School of Medicine at UCLA
Los Angeles, California, 90095, United States
OB/GYN Consult Suite
Los Angeles, California, 90095, United States
Beverly Oncology and Imaging
Montebello, California, 90640, United States
Clinical Trials and Research Associates, Inc.
Montebello, California, 90640, United States
Oncology Care Medical Associates
Montebello, California, 90640, United States
Southwest Cancer Care
Murrieta, California, 92562, United States
Newport Imaging Center
Newport Beach, California, 92660, United States
Gynecologic Oncology Associates
Newport Beach, California, 92663, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663, United States
Kaiser Permanente Medical Center
Oakland, California, 94611, United States
N. County Oncology Medical
Oceanside, California, 92056, United States
Southern California Permanente Medical Group
Panorama City, California, 91402, United States
Southwest Cancer Care
Poway, California, 92064, United States
Southern California Permanente Medical Group
Riverside, California, 92505, United States
Kaiser Permanente Medical Center
Sacramento, California, 95825, United States
Medical Oncology Associates
San Diego, California, 92123, United States
Sharp Memorial Hospital - Investigational Pharmacy
San Diego, California, 92123, United States
Sharp Rees-Stealy
San Diego, California, 92123, United States
Kaiser Permanente Medical Center
San Francisco, California, 94115, United States
Oncology Care Medical Associates
San Gabriel, California, 91776, United States
Kaiser Permanente Medical Center
San Jose, California, 95119, United States
Kaiser Permanente Medical Center
Santa Clara, California, 95051, United States
Kaiser Permanente Medical Center
South San Francisco, California, 94080, United States
Kaiser Permanente Medical Center
Vallejo, California, 94589, United States
Kaiser Permanente Medical Center
Walnut Creek, California, 94596, United States
Diablo Valley Oncology & Hematology Medical Group, Inc.
Walnut Creek, California, 94598, United States
Oncology Care Medical Associates
Whittier, California, 90602, United States
Southern Permanente Medical Group
Woodland Hills, California, 91367, United States
University of Connecticut Health Center/John Dempsey Hospital
Farmington, Connecticut, 06030, United States
The Center for Hematology-Oncology
Boca Raton, Florida, 33486, United States
Citrus Diagnostic Center
Crystal River, Florida, 34428, United States
Citrus Hematology and Oncology Center
Crystal River, Florida, 34428, United States
Citrus Hematology and Oncology Center
Crystal River, Florida, 34429, United States
The Center for Hematology-Oncology
Delray Beach, Florida, 33484, United States
GYN Oncology Associates, Inc.
Hollywood, Florida, 33021, United States
Citrus Hematology and Oncology Center
Inverness, Florida, 34452, United States
Citrus Memorial Hospital Radiology Dept.
Inverness, Florida, 34452, United States
Florida Wellcare Alliance, LC
Inverness, Florida, 34452, United States
Shands Jacksonville Medical Center
Jacksonville, Florida, 32209, United States
Palm Beach Cancer Institute
Jupiter, Florida, 33458, United States
Cancer and Blood Disease Center
Lecanto, Florida, 34461, United States
Florida Hospital
Orlando, Florida, 32803, United States
Gynecology Oncology
Orlando, Florida, 32804, United States
Florida Hospital Memorial Division - Cancer Care Center
Ormond Beach, Florida, 32174, United States
Florida Hospital Memorial System
Ormond Beach, Florida, 32174, United States
Palm Beach Cancer Institute
Palm Beach Gardens, Florida, 33410, United States
GYN Oncology Associates, Inc.
Pembroke Pines, Florida, 33028, United States
Palm Beach Cancer Institute
Wellington, Florida, 33414, United States
Palm Beach Cancer Institute
West Palm Beach, Florida, 33401, United States
Southeastern Gynecologic Oncology
Atlanta, Georgia, 30342, United States
Southeastern Gynecologic Oncology
Lawrenceville, Georgia, 30045, United States
Southeastern Gynecologic Oncology
Marietta, Georgia, 30060, United States
Southeastern Gynecologic Oncology
Riverdale, Georgia, 30274, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Southeastern Gynecologic Oncology
Tucker, Georgia, 30084, United States
Kaiser Permanente Hawaii
Honolulu, Hawaii, 96819, United States
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826, United States
Joliet Oncology-Hematology Associates, Inc.
Flossmoor, Illinois, 60422, United States
Joliet Oncology-Hematology Associates, Inc.
Joliet, Illinois, 60432, United States
Joliet Oncology-Hematology Associates, Inc.
Joliet, Illinois, 60435, United States
Joliet Oncology-Hematology Associates, Inc.
Kankakee, Illinois, 60901, United States
Joliet Oncology-Hematology Associates, Inc.
Morris, Illinois, 60450, United States
Elkhart General Hospital
Elkhart, Indiana, 46514, United States
St. Vincent Hospital
Indianapolis, Indiana, 46260, United States
LaPorte Hospital
La Porte, Indiana, 46350, United States
Memorial Hospital of South Bend
South Bend, Indiana, 46601, United States
Saint Joseph's Regional Medical Center
South Bend, Indiana, 46617, United States
James Graham Brown Cancer Center
Louisville, Kentucky, 40202, United States
University Medical Center, Inc. DBA: U of L Hospital
Louisville, Kentucky, 40202, United States
Hematology and Oncology Specialists, LLC
Covington, Louisiana, 70433, United States
OncRx (Pharmacy)
Metairie, Louisiana, 70002, United States
Hematology and Oncology Specialist
New Orleans, Louisiana, 70006, United States
LSU Health Sciences Center
Shreveport, Louisiana, 71103, United States
Maine Medical Center - Brighton Campus
Portland, Maine, 04102, United States
Maine Medical Center
Portland, Maine, 04102, United States
Maine Medical Center - Scarborough Campus
Scarborough, Maine, 04074, United States
Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Center for Cancer and Blood Disorders, P. C.
Bethesda, Maryland, 20817, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Dana Farber/Partners Cancer Care, Inc.
Boston, Massachusetts, 02115, United States
Boston Medical Center - Center for Cancer and Blood Disorders
Boston, Massachusetts, 02118, United States
Boston Medical Center
Boston, Massachusetts, 02118, United States
Caritas St. Elizabeth's Medical Center
Boston, Massachusetts, 02135, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Perceptive Informatics, Inc.
Waltham, Massachusetts, 02451, United States
Sparrow Health System
Lansing, Michigan, 48912, United States
Lakeland Hospital
Niles, Michigan, 49120, United States
Lakeland Hospital
Saint Joseph, Michigan, 49085, United States
Providence Cancer Institute and Hospital
Southfield, Michigan, 48075, United States
Duluth Clinic
Duluth, Minnesota, 55805, United States
The Family Cancer Center
Olive Branch, Mississippi, 38654, United States
Ellis Fischel Cancer Center
Columbia, Missouri, 65203, United States
Saint Louis University
St Louis, Missouri, 63117, United States
St. John's Mercy Medical Center
St Louis, Missouri, 63141, United States
St. John's Mercy-David C. Pratt Cancer Center
St Louis, Missouri, 63141, United States
Deaconess Billings Clinic
Billings, Montana, 59101, United States
Alegent Health Immanuel Medical Center
Omaha, Nebraska, 68122, United States
Hematology & Oncology Consultants, PC
Omaha, Nebraska, 68122, United States
Horizons West Medical Group
Scottsbluff, Nebraska, 69361, United States
Odyssey Research
Scottsbluff, Nebraska, 69361, United States
Regional West Medical Center
Scottsbluff, Nebraska, 69361, United States
The Women's Center of Western Nebraska
Scottsbluff, Nebraska, 69361, United States
Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
A. Richard Miskoff, DO, PA
Edison, New Jersey, 08818, United States
JFK Medical Center
Edison, New Jersey, 08818, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, 07754, United States
Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
The Cancer Institute of New Jersey
New Brunswick, New Jersey, 08901, United States
Jsumc Ob/Gyn
West Long Branch, New Jersey, 07764, United States
Gynecologic Oncology & Minimally Invasive Surgery
Babylon, New York, 11702, United States
The Mary Imogene Bassett Hospital
Cooperstown, New York, 13326, United States
Schwartz Gynecologic Oncology
East Islip, New York, 11730, United States
North Shore University Hospital
Manhasset, New York, 11030, United States
Hematology-Oncology Associates of Rockland
New City, New York, 10956, United States
Long Island Jewish Medical Center
New Hyde Park, New York, 11040, United States
The Union State Bank Cancer Center
Nyack, New York, 10960, United States
Asheville Radiology
Asheville, North Carolina, 28801, United States
Hope A Women's Cancer Center
Asheville, North Carolina, 28816, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7570, United States
Carolinas Medical Center
Charlotte, North Carolina, 28203, United States
Inpatient Pharmacy
Charlotte, North Carolina, 28203, United States
Blumenthal Cancer Center
Charlotte, North Carolina, 28204, United States
Presbyterian Gynecologic Oncology
Charlotte, North Carolina, 28204, United States
Presbyterian Hospital
Charlotte, North Carolina, 28204, United States
Piedmont Hematology Oncology Associates
Winston-Salem, North Carolina, 27103, United States
Cancer Care Center - Medcenter One, Inc.
Bismarck, North Dakota, 58501, United States
Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.
Bismarck, North Dakota, 58501, United States
Odyssey Research
Bismarck, North Dakota, 58501, United States
Dakota Cancer Institute
Fargo, North Dakota, 58103, United States
Odyssey Research
Fargo, North Dakota, 58104, United States
Barrett Cancer Center
Cincinnati, Ohio, 45219-0501, United States
UC Physician's Medical Arts Building
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
Fairview Hospital Moll Pavilion
Cleveland, Ohio, 44111, United States
Mid Ohio Onc/Hem (East)
Columbus, Ohio, 43213, United States
GOPSA
Columbus, Ohio, 43222, United States
Mid Ohio Onc/Hem (West)
Columbus, Ohio, 43222, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Hillcrest Hospital/Cleveland Clinic Health System
Mayfield Heights, Ohio, 44124, United States
Garth Phibbs, M.D., FACOG
Toledo, Ohio, 43606, United States
ProMedica Health System
Toledo, Ohio, 43606, United States
The Toledo Hospital
Toledo, Ohio, 43606, United States
Mid Onio Onc/Hem (North)
Westerville, Ohio, 43081, United States
Cancer Care Associates
Tulsa, Oklahoma, 74104, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Kaiser Permanente Northwest Region
Portland, Oregon, 97227, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Abington Memorial Hospital
Abington, Pennsylvania, 19001, United States
Advance Imaging
Dunmore, Pennsylvania, 18512, United States
Hematology & Oncology Associates of NEPA
Dunmore, Pennsylvania, 18512, United States
Magee-Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213, United States
Hematology & Oncology Associates of NEPA
Scranton, Pennsylvania, 18508, United States
Viewmont Medical Services
Scranton, Pennsylvania, 18508, United States
Community Medical Center
Scranton, Pennsylvania, 18510, United States
Mercy Health Partners
Scranton, Pennsylvania, 18510, United States
Moses Taylor Hospital
Scranton, Pennsylvania, 18510, United States
Associates in Hematology-Oncology, P.C.
Upland, Pennsylvania, 19013, United States
Roper Hospital-Department of Radiology
Charleston, South Carolina, 29401, United States
Carolina Center of Gynecologic Oncology, PA
Charleston, South Carolina, 29407, United States
South Carolina Oncology
Columbia, South Carolina, 29210, United States
Greenville Hospital System
Greenville, South Carolina, 29605, United States
Spartanburg Regional Healthcare System
Spartanburg, South Carolina, 29303, United States
Sioux Valley Clinic - Clinical Research Center
Sioux Falls, South Dakota, 57104, United States
Sioux Valley Clinic Oncology
Sioux Falls, South Dakota, 57104, United States
Sioux Valley Hospital - North Center Radiology
Sioux Falls, South Dakota, 57104, United States
Sioux Valley Clinic OBGYN, Ltd.
Sioux Falls, South Dakota, 57105, United States
The Family Cancer Center
Bartlett, Tennessee, 38133, United States
Baroness Erlander Hospital
Chattanooga, Tennessee, 37403, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403, United States
Parkridge Medical Center
Chattanooga, Tennessee, 37404, United States
The Family Cancer Center
Collierville, Tennessee, 38017, United States
The Family Cancer Center
Memphis, Tennessee, 38119, United States
Arlington Cancer Center
Arlington, Texas, 76012, United States
Center for Oncology Research and Treatment, PA
Dallas, Texas, 75230, United States
Texas Cancer Associates
Dallas, Texas, 75231, United States
Texas Cancer Associates
Plano, Texas, 75093, United States
Center for Oncology Research and Treatment, PA
Richardson, Texas, 75080, United States
Danville Hematology and Oncology, Inc.
Danville, Virginia, 24541, United States
VCU Health System at Stony Point
Richmond, Virginia, 23235, United States
VCU Health System-Dalton Oncology Clinic, North Hospital
Richmond, Virginia, 23298, United States
Carilion GYN Oncology Associates
Roanoke, Virginia, 24014, United States
Western Washington Oncology, Inc., P.S.
Aberdeen, Washington, 98520, United States
Western Washington Oncology, Inc., P. S.
Centralia, Washington, 98531, United States
Covington MultiCare - Oncology Clinic
Covington, Washington, 98042-4951, United States
Gig Harbor Medical Oncology
Gig Harbor, Washington, 98335, United States
Western Washington Oncology, Inc., P.S.
Lacey, Washington, 98503, United States
Western Washington Oncology, Inc., P.S.
Shelton, Washington, 98584, United States
Allenmore Hospital - Hematology Oncology Clinic
Tacoma, Washington, 98405, United States
MultiCare Health System - Medical Oncology
Tacoma, Washington, 98405, United States
Marshfield Clinic - Chippewa Falls Center
Chippewa Falls, Wisconsin, 54729, United States
Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital
Eau Claire, Wisconsin, 54701, United States
Marshfield Clinic
Marshfield, Wisconsin, 54449, United States
Marshfield Clinic - Lakeland Center
Minocqua, Wisconsin, 54548, United States
Marshfield Clinic - Indianhead Center
Rice Lake, Wisconsin, 54868, United States
St. Michael's Hospital
Stevens Point, Wisconsin, 54481, United States
Marchfield Clinic - Wausau Center
Wausau, Wisconsin, 54401, United States
Marshfield Clinic Weston Center
Weston, Wisconsin, 54476, United States
Marshfield Clinic - Wisconsin Rapids Center
Wisconsin Rapids, Wisconsin, 54494, United States
Related Publications (1)
Newhouse R, Nelissen E, El-Shakankery KH, Rogozinska E, Bain E, Veiga S, Morrison J. Pegylated liposomal doxorubicin for relapsed epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Jul 5;7(7):CD006910. doi: 10.1002/14651858.CD006910.pub3.
PMID: 37407274DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2005
First Posted
February 7, 2005
Study Start
December 1, 2004
Primary Completion
July 1, 2008
Study Completion
July 1, 2008
Last Updated
May 31, 2012
Record last verified: 2006-06