TLK286 (Telcyta) in Combination With Carboplatin (Paraplatin) Versus Doxil in Platinum Refractory or Resistant Ovarian Cancer
- Conditions
- Ovarian Neoplasms
- Interventions
- Drug: TLK286 in Combination with Carboplatin
- Registration Number
- NCT00102973
- Lead Sponsor
- Telik
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 244
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Doxorubisin HCl Liposome Injection Doxorubicin HCl Liposome Injection - TLK286 in Combination with Carboplatin TLK286 in Combination with Carboplatin -
- Primary Outcome Measures
Name Time Method Study Objectives Every 8 Weeks To demonstrate superiority in the objective response rate (ORR) of TLK286 in combination with carboplatin as compared to active control therapy with liposomal doxorubicin
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (171)
Magee-Womens Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
David Geffen School of Medicine at UCLA
🇺🇸Los Angeles, California, United States
Citrus Diagnostic Center
🇺🇸Crystal River, Florida, United States
Clinical Trials and Research Associates, Inc.
🇺🇸Montebello, California, United States
GYN Oncology Associates, Inc.
🇺🇸Pembroke Pines, Florida, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Dana Farber/Partners Cancer Care, Inc.
🇺🇸Boston, Massachusetts, United States
Boston Medical Center - Center for Cancer and Blood Disorders
🇺🇸Boston, Massachusetts, United States
Boston Medical Center
🇺🇸Boston, Massachusetts, United States
Caritas St. Elizabeth's Medical Center
🇺🇸Boston, Massachusetts, United States
Fairview Hospital Moll Pavilion
🇺🇸Cleveland, Ohio, United States
St. Vincent Hospital
🇺🇸Indianapolis, Indiana, United States
UC Physician's Medical Arts Building
🇺🇸Cincinnati, Ohio, United States
Sharp Memorial Hospital - Investigational Pharmacy
🇺🇸San Diego, California, United States
Medical Oncology Associates
🇺🇸San Diego, California, United States
Sharp Rees-Stealy
🇺🇸San Diego, California, United States
Kaiser Permanente Hawaii
🇺🇸Honolulu, Hawaii, United States
VCU Health System at Stony Point
🇺🇸Richmond, Virginia, United States
Southern California Permanente Medical Group
🇺🇸Riverside, California, United States
Hoag Memorial Hospital Presbyterian
🇺🇸Newport Beach, California, United States
Southeastern Gynecologic Oncology
🇺🇸Tucker, Georgia, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Barrett Cancer Center
🇺🇸Cincinnati, Ohio, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Presbyterian Gynecologic Oncology
🇺🇸Charlotte, North Carolina, United States
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Mid Onio Onc/Hem (North)
🇺🇸Westerville, Ohio, United States
Cancer Care Associates
🇺🇸Tulsa, Oklahoma, United States
Hematology & Oncology Associates of NEPA
🇺🇸Scranton, Pennsylvania, United States
Viewmont Medical Services
🇺🇸Scranton, Pennsylvania, United States
Advance Imaging
🇺🇸Dunmore, Pennsylvania, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, United States
Mercy Health Partners
🇺🇸Scranton, Pennsylvania, United States
Moses Taylor Hospital
🇺🇸Scranton, Pennsylvania, United States
Western Washington Oncology, Inc., P.S.
🇺🇸Shelton, Washington, United States
Gig Harbor Medical Oncology
🇺🇸Gig Harbor, Washington, United States
Allenmore Hospital - Hematology Oncology Clinic
🇺🇸Tacoma, Washington, United States
Duluth Clinic
🇺🇸Duluth, Minnesota, United States
Cancer Treatment & Research Center - Mid Dakota Clinic, P. C.
🇺🇸Bismarck, North Dakota, United States
Dakota Cancer Institute
🇺🇸Fargo, North Dakota, United States
Gynecology Oncology
🇺🇸Orlando, Florida, United States
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
Florida Wellcare Alliance, LC
🇺🇸Inverness, Florida, United States
University of Connecticut Health Center/John Dempsey Hospital
🇺🇸Farmington, Connecticut, United States
Florida Hospital Memorial System
🇺🇸Ormond Beach, Florida, United States
Maine Medical Center - Brighton Campus
🇺🇸Portland, Maine, United States
Baroness Erlander Hospital
🇺🇸Chattanooga, Tennessee, United States
Maine Medical Center - Scarborough Campus
🇺🇸Scarborough, Maine, United States
Shands Jacksonville Medical Center
🇺🇸Jacksonville, Florida, United States
Sioux Valley Clinic Oncology
🇺🇸Sioux Falls, South Dakota, United States
Florida Hospital Memorial Division - Cancer Care Center
🇺🇸Ormond Beach, Florida, United States
OncRx (Pharmacy)
🇺🇸Metairie, Louisiana, United States
Citrus Hematology and Oncology Center
🇺🇸Inverness, Florida, United States
The Center for Hematology-Oncology
🇺🇸Delray Beach, Florida, United States
Palm Beach Cancer Institute
🇺🇸West Palm Beach, Florida, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Sparrow Health System
🇺🇸Lansing, Michigan, United States
Little Rock Hematology Oncology
🇺🇸Little Rock, Arkansas, United States
Arkansas Oncology Associates
🇺🇸Little Rock, Arkansas, United States
Hematology and Oncology Specialists, LLC
🇺🇸Covington, Louisiana, United States
Horizons West Medical Group
🇺🇸Scottsbluff, Nebraska, United States
Perceptive Informatics, Inc.
🇺🇸Waltham, Massachusetts, United States
JFK Medical Center
🇺🇸Edison, New Jersey, United States
Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Maine Medical Center
🇺🇸Portland, Maine, United States
Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Spartanburg Regional Healthcare System
🇺🇸Spartanburg, South Carolina, United States
Providence Cancer Institute and Hospital
🇺🇸Southfield, Michigan, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Sioux Valley Clinic - Clinical Research Center
🇺🇸Sioux Falls, South Dakota, United States
Cancer and Blood Disease Center
🇺🇸Lecanto, Florida, United States
Jsumc Ob/Gyn
🇺🇸West Long Branch, New Jersey, United States
Mary Hitchcock Memorial Hospital/Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
The Cancer Institute of New Jersey
🇺🇸New Brunswick, New Jersey, United States
South Carolina Oncology
🇺🇸Columbia, South Carolina, United States
Marshfield Clinic
🇺🇸Marshfield, Wisconsin, United States
Deaconess Billings Clinic
🇺🇸Billings, Montana, United States
Greenville Hospital System
🇺🇸Greenville, South Carolina, United States
Sioux Valley Hospital - North Center Radiology
🇺🇸Sioux Falls, South Dakota, United States
Sioux Valley Clinic OBGYN, Ltd.
🇺🇸Sioux Falls, South Dakota, United States
Robert Wood Johnson University Hospital
🇺🇸New Brunswick, New Jersey, United States
Regional West Medical Center
🇺🇸Scottsbluff, Nebraska, United States
Chattanooga GYN Oncology
🇺🇸Chattanooga, Tennessee, United States
St. Michael's Hospital
🇺🇸Stevens Point, Wisconsin, United States
Parkridge Medical Center
🇺🇸Chattanooga, Tennessee, United States
Marchfield Clinic - Wausau Center
🇺🇸Wausau, Wisconsin, United States
Marshfield Clinic - Chippewa Falls Center
🇺🇸Chippewa Falls, Wisconsin, United States
Marshfield Clinic Weston Center
🇺🇸Weston, Wisconsin, United States
Marshfield Clinic Cancer Care - Regional Cancer Center - Sacred Heart Hospital
🇺🇸Eau Claire, Wisconsin, United States
Marshfield Clinic - Wisconsin Rapids Center
🇺🇸Wisconsin Rapids, Wisconsin, United States
Marshfield Clinic - Lakeland Center
🇺🇸Minocqua, Wisconsin, United States
Marshfield Clinic - Indianhead Center
🇺🇸Rice Lake, Wisconsin, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
Kaiser Permanente Northwest Region
🇺🇸Portland, Oregon, United States
Center for Cancer and Blood Disorders, P. C.
🇺🇸Bethesda, Maryland, United States
Alegent Health Immanuel Medical Center
🇺🇸Omaha, Nebraska, United States
Hematology & Oncology Consultants, PC
🇺🇸Omaha, Nebraska, United States
LaPorte Hospital
🇺🇸LaPorte, Indiana, United States
Citrus Memorial Hospital Radiology Dept.
🇺🇸Inverness, Florida, United States
The Union State Bank Cancer Center
🇺🇸Nyack, New York, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Elkhart General Hospital
🇺🇸Elkhart, Indiana, United States
Memorial Hospital of South Bend
🇺🇸South Bend, Indiana, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Asheville Radiology
🇺🇸Asheville, North Carolina, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Saint Joseph's Regional Medical Center
🇺🇸South Bend, Indiana, United States
Joliet Oncology-Hematology Associates, Inc.
🇺🇸Morris, Illinois, United States
Lakeland Hospital
🇺🇸St. Joseph, Michigan, United States
Ellis Fischel Cancer Center
🇺🇸Columbia, Missouri, United States
Hematology-Oncology Associates of Rockland
🇺🇸New City, New York, United States
Saint Louis University
🇺🇸St. Louis, Missouri, United States
St. John's Mercy Medical Center
🇺🇸St. Louis, Missouri, United States
Inpatient Pharmacy
🇺🇸Charlotte, North Carolina, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
Garth Phibbs, M.D., FACOG
🇺🇸Toledo, Ohio, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Mid Ohio Onc/Hem (East)
🇺🇸Columbus, Ohio, United States
GOPSA
🇺🇸Columbus, Ohio, United States
Hillcrest Hospital/Cleveland Clinic Health System
🇺🇸Mayfield Heights, Ohio, United States
Mid Ohio Onc/Hem (West)
🇺🇸Columbus, Ohio, United States
Associates in Hematology-Oncology, P.C.
🇺🇸Upland, Pennsylvania, United States
Community Medical Center
🇺🇸Scranton, Pennsylvania, United States
Texas Cancer Associates
🇺🇸Plano, Texas, United States
Western Washington Oncology, Inc., P. S.
🇺🇸Centralia, Washington, United States
Center for Oncology Research and Treatment, PA
🇺🇸Richardson, Texas, United States
Arlington Cancer Center
🇺🇸Arlington, Texas, United States
Carilion GYN Oncology Associates
🇺🇸Roanoke, Virginia, United States
Danville Hematology and Oncology, Inc.
🇺🇸Danville, Virginia, United States
Covington MultiCare - Oncology Clinic
🇺🇸Covington, Washington, United States
MultiCare Health System - Medical Oncology
🇺🇸Tacoma, Washington, United States
Cancer Care Center - Medcenter One, Inc.
🇺🇸Bismarck, North Dakota, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
East Bay Oncology/Hematology Medical Associates, Inc.
🇺🇸Concord, California, United States
Southwest Cancer Care
🇺🇸Poway, California, United States
California Oncology of the Central Valley
🇺🇸Fresno, California, United States
Marilyn Norton, M.D.
🇺🇸Chula Vista, California, United States
Bay Area Cancer Research Group, LLC
🇺🇸Concord, California, United States
Kaiser Permanente Medical Center
🇺🇸Walnut Creek, California, United States
Cancer Center Oncology Medical Group
🇺🇸La Mesa, California, United States
LLU Faculty Medical Offices
🇺🇸Loma Linda, California, United States
Bowyer Oncology Center
🇺🇸Los Angeles, California, United States
OB/GYN Consult Suite
🇺🇸Los Angeles, California, United States
Oncology Care Medical Associates
🇺🇸Whittier, California, United States
Newport Imaging Center
🇺🇸Newport Beach, California, United States
Beverly Oncology and Imaging
🇺🇸Montebello, California, United States
N. County Oncology Medical
🇺🇸Oceanside, California, United States
Diablo Valley Oncology & Hematology Medical Group, Inc.
🇺🇸Walnut Creek, California, United States
Southern Permanente Medical Group
🇺🇸Woodland Hills, California, United States
The Family Cancer Center
🇺🇸Memphis, Tennessee, United States
St. John's Mercy-David C. Pratt Cancer Center
🇺🇸St. Louis, Missouri, United States
The Women's Center of Western Nebraska
🇺🇸Scottsbluff, Nebraska, United States
Odyssey Research
🇺🇸Fargo, North Dakota, United States
A. Richard Miskoff, DO, PA
🇺🇸Edison, New Jersey, United States
Gynecologic Oncology & Minimally Invasive Surgery
🇺🇸Babylon, New York, United States
The Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Schwartz Gynecologic Oncology
🇺🇸East Islip, New York, United States
Piedmont Hematology Oncology Associates
🇺🇸Winston Salem, North Carolina, United States
ProMedica Health System
🇺🇸Toledo, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Gynecologic Oncology Associates
🇺🇸Newport Beach, California, United States
Loma Linda University Medical Center
🇺🇸Loma Linda, California, United States
James Graham Brown Cancer Center
🇺🇸Louisville, Kentucky, United States
University Medical Center, Inc. DBA: U of L Hospital
🇺🇸Louisville, Kentucky, United States
University of North Carolina at Chapel Hill
🇺🇸Chapel Hill, North Carolina, United States
Roper Hospital-Department of Radiology
🇺🇸Charleston, South Carolina, United States
Carolina Center of Gynecologic Oncology, PA
🇺🇸Charleston, South Carolina, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
Hematology and Oncology Specialist
🇺🇸New Orleans, Louisiana, United States
VCU Health System-Dalton Oncology Clinic, North Hospital
🇺🇸Richmond, Virginia, United States