TLK286 (Telcyta) vs. Doxil/Caelyx or Hycamtin in Platinum Refractory or Resistant Ovarian Cancer
Summary
The purpose of this study is to demonstrate superiority in survival in favor of TLK286 as compared to active control therapy with Doxil/Caelyx or Hycamtin in the intent-to-treat (ITT) populations.
Key Facts
Lead Sponsor
Telik
Enrollment
440
Start Date
2003-06-01
Completion Date
2006-12-01
Study Type
INTERVENTIONAL
Official Title
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)]
Interventions
Conditions
Eligibility
Age Range
18 Years+
Sex
FEMALE
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 entry * Pregnant or lactating women
Locations
Little Rock Hematology Oncology Associates, Little Rock, United States
University of Arkansas for Medical Sciences, Little Rock, United States
Southern California Permanente Medical Group, Baldwin Park, United States
Providence Saint Joseph Medical Center, Burbank, United States
Marilyn Norton, M. D., Chula Vista, United States
Rosalba Rodriguez, M. D., Chula Vista, United States
Bay Area Research Cancer Group, Concord, United States
Southwest Cancer Care, Escondido, United States
California Oncology of the Central Valley, Fresno, United States
Kaiser Permanente Oncology Clinical Trials Program, Hayward, United States
Gynecologic Oncology Associates, La Jolla, United States
Grossmont Hospital, La Mesa, United States
Sharp Rees-Stealy, La Mesa, United States
LLU Faculty Medical Offices, Loma Linda, United States
LLU Faculty Meidical Offices, Loma Linda, United States
Loma Linda University Medical Center, Loma Linda, United States
David Geffen School of Medicine at UCLA, Los Angeles, United States
Women's Cancer Center - Community Hospital Los Gatos, Los Gatos, United States
Southwest Cancer Care, Murrieta, United States
Gyncologic Oncology Associates, Newport Beach, United States
Kaiser Permanente Oncology Clinical Trials Program, Oakland, United States
N. County Oncology Medical, Oceanside, United States
Southwest Cancer Care, Poway, United States
Kaiser Permanente Oncology Clinical Trials Program, Redwood City, United States
Kaiser Permanente Oncology Clinical Trials Program, Roseville, United States
Kaiser Permanente Oncology Clinical Trials Program, Sacramento, United States
Southern California Permanente Medical Group, San Diego, United States
Medical Oncology Associates-SD, San Diego, United States
Sharp Healthcare Clinical Oncology Research, San Diego, United States
Sharp Memorial Hospital, San Diego, United States
Sharp Rees-Stealy, San Diego, United States
Kaiser Permanente Oncology Clinical Trials Program, San Francisco, United States
Kaiser Permanente Oncology Clinical Trials Program, San Rafael, United States
Kaiser Permanente Oncology Clinical Trials Program, Santa Clara, United States
Kaiser Permanente Oncology Clinical Trials Program, Santa Rosa, United States
Kaiser Permanente Oncology Clinical Trails Program, Santa Teresa, United States
Kaiser Permanente Oncology Clinical Trials Program, South San Francisco, United States
Kaiser Permanente Oncology Clinical Trials Program, Vallejo, United States
Kaiser Permanente Oncology Clinial Trials Program, Walnut Creek, United States
Whittingham Cancer Center at Norwalk Hospital, Norwalk, United States
Hematology Oncology, P.C., Stamford, United States
The Center for Hematology-Oncology, Boca Raton, United States
The Center for Hematology-Oncology, Delray Beach, United States
Memorial Regional Hospital, Hollywood, United States
Sheridan Clinical Research, Inc., Hollywood, United States
University of Florida Health Science Center/Jacksonville, Jacksonville, United States
Florida Hospital, Orlando, United States
Gynecologic Oncology, Orlando, United States
Florida Hospital Memorial Division, Cancer Care Center, Ormond Beach, United States
Florida Hospital Memorial Division, Ormond Beach, United States
Palm Beach Cancer Institute, Palm Beach Gardens, United States
Gynecologic Oncology Associates, Pembroke Pines, United States
Hematology/Oncology Associates of Treasure Coast, Port Saint Lucie, United States
Women's Cancer Research Foundation, Inc., South Miami, United States
Palm Beach Cancer Institute, Wellington, United States
Palm Beach Cancer Institute, West Palm Beach, United States
Suburban Hematology Oncology, Duluth, United States
Suburban Hematology-Oncology Associates, Lawrenceville, United States
Memorial Health University Medical Center, Savannah, United States
Suburban Hematology Oncology, Snellville, United States
Kaiser Permanente - Moanalua Medical Center, Honolulu, United States
Straub Clinic and Hospital, Honolulu, United States
Univ. of Hawaii, Kapiolani Medical Center for Women and Children, Honolulu, United States
North Shore Oncology Hematology Associates, Barrington, United States
MacNeal Cancer Center, Berwyn, United States
Swedish Covenant Cancer Center, Chicago, United States
Hematology Oncology Associates of Illinois (HOAI), Chicago, United States
Cancer Care Specialists of Central IL, Decatur, United States
Decatur Memorial Hospital, Decatur, United States
Cancer Care Specialists of Central IL-Crossroads Cancer Care Center, Effingham, United States
Joliet Oncology-Hematology Associates, Ltd., Flossmoor, United States
Joliet Oncology-Hematology Associates, Ltd., Joliet, United States
North Shore Oncology Hematology Associates - Deerpath Medical Associates, Lake Forest, United States
North Shore Oncology Hematology Associates, Libertyville, United States
North Shore Oncology Hematology Associates, McHenry, United States
Joliet Oncology-Hematology Associates, Ltd., Morris, United States
Hematology Oncology Associates of Illinois (HOAI), Skokie, United States
Midwest Cancer Research Group, Inc., Skokie, United States
Elkhart General Hospital, Elkhart, United States
Michiana Hematology Oncology, Elkhart, United States
Indiana Cancer Pavilion, Indianapolis, United States
Indiana University Medical Center, Indianapolis, United States
St. Vincent Gynecologic Oncology, Indianapolis, United States
St. Vincent Hospital and Health Care Center, Indianapolis, United States
St. Vincent Hospital and Helath Care Center, Indianapolis, United States
Michiana Hematology Oncology, South Bend, United States
St. Joseph's Regional, South Bend, United States
Saint Joseph's Regional, South Bend, United States
University of Iowa Hospitals and Clinics, Iowa City, United States
University of Iowa, Iowa City, United States
Research Support Personnel, LLC, Wichita, United States
Associates in Women's Health, Wichita, United States
Oncology/Hematology Care, Inc., Crestview, United States
Univ. of Louisville, Div. of Gynecologic Oncology, Louisville, United States
Hematology and Oncology Specialists, LLC, Covington, United States
OncRx (Pharmacy), Metairie, United States
Hematology and Oncology Specialists, LLC, New Orleans, United States
Ochsner Clinic Foundation, New Orleans, United States
LSU Health Sciences Center, Shreveport, United States
Sinai Cancer Institute, Baltimore, United States
Center for Cancer and Blood Disorders, Bethesda, United States
St. Elizabeth's Med. Ctr., Boston, United States
St. Joseph Mercy Hospital, Ann Arbor, United States
Sparrow Regional Cancer Center, Lansing, United States
St. Mary's Duluth Clinic, Duluth, United States
Ellis Fischel Cancer Center, Columbia, United States
St. Louis University, Dept. of Ob-Gyn and Women's Health, St Louis, United States
Gynecology & Oncology Consultants, PC, St Louis, United States
Saint John's Mercy Hospital, St Louis, United States
Deaconess Billings Clinic, Billings, United States
Hematology & Oncology Centers Northern Rockies, Billings, United States
Hematology Oncology Centers of the Northern Rockies, Butte, United States
Horizon's West Medical Group, Scottsbluff, United States
Nevada Cancer Center, Las Vegas, United States
Jersey Shore University Medical Center, Neptune City, United States
The Cancer Institute of New Jersey, New Brunswick, United States
Robert Wood Johnson University Hospital, New Brunswick, United States
UNM Cancer Research and Treatment Center, Albuquerque, United States
Benjamin Schwartz, M.D., Babylon, United States
The Mary Imogene Bassett Hospital, Cooperstown, United States
Med-Onc/Hem, Malone, United States
Hematology-Oncology Associates of Rockland, New City, United States
Long Island Jewish Medical Center, New Hyde Park, United States
North Shore-Long Island Jewish Health System/Medical Center, New Hyde Park, United States
Bellevue Hospital Center, New York, United States
Comprehensive Cancer Center Medical Practice Offices, New York, United States
New York University Medical Center - Tisch Hospital, New York, United States
NYU School of Medicine, New York, United States
Memorial Sloan Kettering Cancer Center, New York, United States
The Union State Bank Cancer Center at Nyack Hospital, Nyack, United States
Gynecologic-Oncology, Rochester, United States
Good Samaritan Hospital Medical Center, West Islip, United States
South Bay OB/GYN, West Islip, United States
Blumenthal Cancer Center, Charlotte, United States
Presbyterian Gynecologic Oncology, Charlotte, United States
Presbyterian Hospital Center for Cancer Research, Charlotte, United States
Piedmont Hematology Oncology Assoc., PA-Salem Research Group, Winston-Salem, United States
Salem Research Group, Inc., Winston-Salem, United States
Wake Forest University School of Medicine, Winston-Salem, United States
Mid Dakota Clinic, Bismarck, United States
Odyssey Research Services, Bismarck, United States
Dakota Cancer Institute, Fargo, United States
Odyssey Research Services, Fargo, United States
Oncology/Hematology Care, Inc., Cincinnati, United States
Barrett Cancer Center, Cincinnati, United States
Barrett Cancer Center, Cincinnati, United States
Oncology/Hematology Care, Inc., Cincinnati, United States
UC Physician's Medical Arts Bldg., Cincinnati, United States
UC Physician's Medical Arts Building, Cincinnati, United States
University Hospital, Cincinnati, United States
Oncology/Hematology Care, Inc., Cincinnati, United States
Oncology/Hematology Care, Inc., Cincinnati, United States
Oncology/Hematology Care, Inc., Cincinnati, United States
Metro Health Medical Center, Cleveland, United States
MetroHealth Medical Center, Cleveland, United States
Mid-Ohio Oncology Hematology St. Anne's, Columbus, United States
Mid Ohio Oncology Hematology, Columbus, United States
Mid-Ohio Oncology Hematology, Columbus, United States
Gynecologic Oncology, Columbus, United States
Mount Carmel Health, Columbus, United States
Wright State Univ. School of Medicine, Dayton, United States
Hillcrest Hospital Cancer Center, Mayfield Heights, United States
OU Medical Center - Everett Tower, Oklahoma City, United States
OU Physicians' Bldg., Oklahoma City, United States
Presbyterian, Oklahoma City, United States
University of Oklahoma Health Sciences Center, Oklahoma City, United States
Kaiser Permanente Nw, Oncology Research, Portland, United States
Oregon Health & Science University, Portland, United States
Oregon Health Science University, Portland, United States
Abington Mem. Hospita/Rosenfield Cancer Center, Abington, United States
Advanced Imaging, Dunmore, United States
Hematology & Oncology Associates of NEPA, Dunmore, United States
Magee-Womens Hospital, Pittsburgh, United States
Viewmont Medical Services, Scranton, United States
Community Medical Center, Scranton, United States
Mercy Health Partners, Scranton, United States
Moses Taylor Hospital, Scranton, United States
Associates in Hematology-Oncology, P.C., Upland, United States
Carolina Center of Gynecologic Oncology, PA, Charleston, United States
South Carolina Oncology Associates, PA, Columbia, United States
Gynecologic Oncology Research and Development, Greenville, United States
Gynecologic Oncology Research and Development, Spartanburg, United States
Sioux Valley Clinic Clinical Research Center, Sioux Falls, United States
Sioux Valley Clinic Oncology, Sioux Falls, United States
Sioux Valley Hospital - North Center Radiology, Sioux Falls, United States
Sioux Calley Clinic OBGYN Ltd., Sioux Falls, United States
Chattanooga Oncology & Hematology Associates, P.C., Chattanooga, United States
Memorial Hospital, Chattanooga, United States
The Consultant Group, Franklin, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Gallatin, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Hermitage, United States
Saint Mary's Health System, Inc., Knoxville, United States
Hall and Martin, M.D.'s, P.C., Knoxville, United States
Fort Sanders Parkwest Medical Center, Knoxville, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Lebanon, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Murfreesboro, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Nashville, United States
The Consultant Group, Nashville, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Nashville, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Nashville, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Nashville, United States
The Sarah Cannon Cancer Center/Tennessee Oncology, PLLC, Smyma, United States
Amarillo Cancer Center, Amarillo, United States
Arlington Cancer Center, Arlington, United States
Dallas Oncology Consultants, Dallas, United States
Texas Cancer Associates, Dallas, United States
Texas Oncology, PA, Fort Worth, United States
Southwest Fort Worth Cancer Center, Fort Worth, United States
Univ. of TX, MD Anderson Cancer Center, Houston, United States
Danville Hematology and Oncology, Inc., Danville, United States
Western Washington Oncology, Aberdeen, United States
Western Washington Oncology, Centralia, United States
Covington Multicare - Oncology Clinic, Covington, United States
Western Washington Oncology, Olympia, United States
Western Washington Oncology, Olympia, United States
Western Washington Oncology, Shelton, United States
Allenmore Hospital - Hematology Oncology Clinic, Tacoma, United States
MultiCare Health System - Medical Oncology, Tacoma, United States
Chippewa Falls Cancer Center, Chippewa Falls, United States
Regional Cancer Center, Eau Claire, United States
Marshfield Clinic Research Foundation, Marshfield, United States
Saint Joseph's Hospital, Marshfield, United States
Wisconsin Rapid Cancer Center, Marshfield, United States
Merrill Cancer Center, Merrill, United States
Medical Consultants, Ltd., Milwaukee, United States
Marshfield Clinc - Lakeland Center, Minocqua, United States
Marshfield Clinic - Lakeland Center, Minocqua, United States
Diagnostic Radiology Associates, Rice Lake, United States
Lakeview Medical Center, Rice Lake, United States
Marshfield Clinic - Indianhead Center, Rice Lake, United States
Saint Michael Hospital, Stevens Point, United States
Wausau Cancer Center, Wausau, United States
Hematology Oncology Centers of the Northern Rockies, Cody, United States
Hematology Oncology of the Northern Rockies, Sheridan, United States
Hospital Italiano Regional del Sur, Bahía Blanca, Argentina
Hospital Italiano de Buenos Aires, Buenos Aires, Argentina
Sanatorio Municipal Dr. Julio Mendez, Buenos Aires, Argentina
Hospital General de Agudos "Carlos G. Durand", Buenos Aires, Argentina
Complejo Medico de la Policia Federal Argentina "Churruca-Visca", Buenos Aires, Argentina
Hospital de Oncologia Maria Curie, Buenos Aires, Argentina
Policlinica Privada Instituto de Medicina Nuclear, Buenos Aires, Argentina
Hospital General de Agudos Donacion F. Santojanni, Capital Federal, Argentina
Hospital Universitario Austral, Pilar, Argentina
ISIS Clinica Especializada, Santa Fe, Argentina
Hospital Donacion Francisco Santojanni, Buenos Aires, Argentina
Complejo Medico de la Policia Federal Argentina "Churruca-Visca", Buenos Aires, Argentina
Sociedad de Beneficencia Hospital Italiano, Córdoba, Argentina
Algemeen Ziekenhuis Antwerpen, Lindedreef, Belgium
Universitaire Ziekenhuis Antwerpen, Wilrijkstraat, Belgium
University Hospital Gasthuisberg, Herestraat, Belgium
AZ-VUB Dienst Oncologie, Brussels, Belgium
Cliniques Universitaires Saint-Luc, Brussels, Belgium
Universitair Ziekenhuis Gent., Ghent, Belgium
Centre Hospitalier Regional de la Citadelle, Liège, Belgium
Instituto do Cancer do Ceara, Fortaleza, Brazil
Hospital Vera Cruz, Belo Horizonte, Brazil
Hospital Luxemburgo, Belo Horizonte, Brazil
Hospital de Clinicas da Universidade Federal do Parana, Curitiba, Brazil
Centro de Tratamento Oncologico de Londrina, Londrina, Brazil
Hospital de Clinicas de Porto Alegre, Bairro Bom Fim, Brazil
INCA Hospital de Oncologia Clinica, Rio de Janeiro, Brazil
Instituto Arnaldo Vieira de Carvalho, São Paulo, Brazil
Hospital do Cancer - A.C. Camargo, São Paulo, Brazil
Unifesp/Epm, São Paulo, Brazil
Hospital das Clinicas de Sao Paulo-FMUSP, São Paulo, Brazil
Instituto de Saude e Bem Estar da Mulher, São Paulo, Brazil
Clinica Santa Maria, Santiago, Chile
Servicio de Oncologia-Hospital Clinico Unversidad de Chile, Independencia, Chile
Fakultni nemocnice Olomouc, Onkologicka klinika, Pardubice, Czechia
Krajska nemocnice Pardubice, Oddeleni radiacni onklogie, Kyjevska 44, Czechia
Fakultni Nemocnice - Onkologicka Klinika, Doudlevecka 69, Czechia
Vseobecna Fakultni Nemocnice - Onkologicka Klinika, Unemocnice, Czechia
Batova krajska nemocnice Zlin, prispevkova organizace, Onkologicke oddeleni, Havlickovo Nabrezi 600, Czechia
Batova krajska nemocnice Zlin, prispevkova organizace, Radiodiagnosticke oddeleni, Havlickovo Nabrezi, Czechia
Masarykuv Onkologicky Ustav, Brno, Czechia
Fakultni nemocnice, Onkologicka klinika, Pilsen, Czechia
Universitatsklinikum Charite - Campus Virchow-Klinikum, Berlin, Germany
St. Vincentius Kliniken, Karlsruhe, Germany
St. Vincentius Kliniken - Frauenkinik, Karlsruhe, Germany
St. Vincentius Kliniken - Radiology, Karlsruhe, Germany
Klinikum GroBhadern-Institut fur Radiologie, Munich, Germany
Klinikum GroBhadern-Zentrum fur Frauenheilkunde, Munich, Germany
Universitaets-Frauenklinik Ulm, Ulm, Germany
Dr. Horst-Schmidt-Kliniken GmbH, Wiesbaden, Germany
Semmelweis University, 1st Dept. of Obstetrics and Gynaecology, Baross, Hungary
Uzsoki Street Hospital Dept. of Radiooncology, Budapest, Hungary
Faculty of Gynaecologycal Oncology/Univ. of Debrecen, Debrecen, Hungary
Baranya County Hospital, Pécs, Hungary
Baranya County Hospital - Department of Oncology, Rakoczi, Hungary
Baranya County Hospital - Department of Radiology, Rakoczi, Hungary
SZTE, Department of Oncotherapy, Szeged, Hungary
Oncology Dept., University Floor, Belfast City Hospital, Belfast, Ireland
Vrije Universiteit Medical Centre (VUMC), HV Amsterdam, Netherlands
University Medical Centre Nijmegen (UMCN), Nijmegen, Netherlands
Panorama Medical Centre, Panorama, South Africa
Hopelands Cancer Centre, Overport, South Africa
Medical and Dental Centre, Rosebank, South Africa
Rosebank Oncology Centre, Saxonwold, South Africa
Wilgers Oncology Centre, Die Wilgers X14, South Africa
Eastern Cape Oncology Research Centre, Port Elizabeth, South Africa
Servicio Oncologia Hospital General Vall d'HebronPaseo, Vall d'Hebron, Spain
Instituto Valenciano de Oncologia (IVO), Profesor Beltran Baguena, Spain
Hospital Clinic i Provincial de Barcelona - Servicio de Oncologia Medica, Barcelona, Spain
Hospital Clinic i Provincial, Barcelona, Spain
Hospital General de Guadalajara, Guadalajara, Spain
Servicio de Oncologia, Madrid, Spain
Instituto Valenciano de Oncologia (IVO) Servicio de Oncologia, Valencia, Spain
Instituto Valenciano de Oncologia (IVO) Servicio de Radiologia, Valencia, Spain
Department of Cancer Medicine - Ninewells Hospital & Medical School, Scotland, United Kingdom
Dept. of Med. Oncology/The Royal Marsden Hospital, Sutton, United Kingdom
St. Chad's Outpatients Unit, City Hospital, Birmingham, United Kingdom
United Bristol Healthcare Trust - Bristol Oncology Centre, Bristol, United Kingdom
Beatson Oncology Centre, Glasgow, United Kingdom
Beatson Oncology Unit, Glasgow, United Kingdom
Medical Oncology - Guy's and St. Thomas' Hospital, London, United Kingdom
Department of Medicine-Royal Marsden Hospital, London, United Kingdom
Department of Medical Oncology, Christie Hospital, Manchester, United Kingdom
Medical Oncology (NCCT) - Newcastle General Hospital, Newcastle upon Tyne, United Kingdom
Dorset Cancer Centre - Poole Hospital, Poole, United Kingdom
Velindre NHS Trust - Velindre Hospital, Wales, United Kingdom