Spots Global Cancer Trial Database for Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
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Trial Identification
Brief Title: Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
Official Title: 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)
Study ID: NCT00350948
Conditions
Study Description
Brief Summary: The purpose of this research study is to determine if Telcyta® given in combination with liposomal doxorubicin is more effective than liposomal doxorubicin alone 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: This is a randomized, open label, multicenter, multinational Phase 3 study of TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) as compared to the active control therapy with liposomal doxorubicin (Doxil/Caelyx) as second line therapy in patients with platinum refractory or resistant recurrent ovarian cancer. Patients will be randomly assigned to receive either TLK286 (Telcyta) in combination with liposomal doxorubicin (Doxil/Caelyx) or active control liposomal doxorubicin (Doxil/Caelyx).
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Desert Oasis Cancer Center, Casa Grande, Arizona, United States
Hematology Oncology Services of Arkansas, Little Rock, Arkansas, United States
University of Arkansas for Medical Sciences, Little Rock, Arkansas, United States
East Bay Medical Oncology/Hematology Medical Associates, Inc., Antioch, California, United States
Bay Area Cancer Research Group, LLC, Concord, California, United States
East Bay Medical Oncology/Hematology Medical Associates, Concord, California, United States
California Oncology of the Central Valley, Fresno, California, United States
Women's Cancer Research Foundation, Newport Beach, California, United States
Southwest Cancer Care, Poway, California, United States
Desert Hematology Oncology Medical Group, Rancho Mirage, California, United States
Southern California Permanente Medical Group, San Diego, California, United States
East Bay Medical Oncoogy/Hematology Medical Associates, Inc., San Leandro, California, United States
Diablo Valley Oncology & Hematology Medical Group, Inc., Walnut Creek, California, United States
Gynecologic Oncology Associates, Inc, Hollywood, Florida, United States
Shands Jacksonville Medical Center, Jacksonville, Florida, United States
University of Florida College of Medicine-Jacksonville, Jacksonville, Florida, United States
Florida Hospital Cancer Institute, Orlando, Florida, United States
Florida Hospital, Orlando, Florida, United States
Gynecologic Oncology Associates, Inc, Pembroke Pines, Florida, United States
Memorial Health University Medical Center, Savannah, Georgia, United States
Kaiser Permanente Moanalua Medical Center, Honolulu, Hawaii, United States
Flossmoor Cancer Care (JOHA DBA), Flossmoor, Illinois, United States
Joliet Oncology-Hematology Associates, Joliet, Illinois, United States
Joliet Oncology-Hematology Associates, LTD., Joliet, Illinois, United States
Kankakee Cancer Center (JOHA DBA), Kankakee, Illinois, United States
Joliet Oncology-Hematology Associates, Morris, Illinois, United States
St. Vincent Gynecologic Oncology, Indianapolis, Indiana, United States
Central Baptist Hospital, Lexington, Kentucky, United States
Hematology and Oncology Specialists, LLC, Metairie, Louisiana, United States
LSU Health Sciences Center, Shreveport, Louisiana, United States
Center for Cancer and Blood Disorders, Bethesda, Maryland, United States
Arch Medical Services, St. Louis, Missouri, United States
Hematology & Oncology Consultants P.C., Omaha, Nebraska, United States
Horizon's West Medical Group, Scottsbluff, Nebraska, United States
The Women's Center of Western Nebraska, Scottsbluff, Nebraska, United States
Schwaartz Gynecologic Oncology, PLLC, Babylon, New York, United States
The Mary Imogene Bassett Hospital, Cooperstown, New York, United States
Monter Cancer Center, Lake Success, New York, United States
North Shore University Hospital, Manhasset, New York, United States
Long Island Jewish Medical Center, New Hyde Park, New York, United States
Hope A Women's Cancer Center, Asheville, North Carolina, United States
Blumenthal Cancer Center, Charlotte, North Carolina, United States
Carolinas Medical Center, Charlotte, North Carolina, United States
Presbyterian Hospital, Charlotte, North Carolina, United States
Piedmont Hematology Oncology Associates-Lexington Satellite, Lexington, North Carolina, United States
Piedmont Hematology Oncology Associates, Winston Salem, North Carolina, United States
Dakota Cancer Institute/Dakota Clinic Ltd., Fargo, North Dakota, United States
Gynecologic Oncology & Pelvic Surgery Associates, Columbus, Ohio, United States
Garth Phibbs, M.D., FACOG, Toledo, Ohio, United States
The Toledo Hospital, Toledo, Ohio, United States
Kaiser Permanente NW, Oncology/Hematology, Portland, Oregon, United States
Oregon Health & Science University, Portland, Oregon, United States
Abington Memorial Hospital, Abington, Pennsylvania, United States
Hematology & Oncology Associates of NEPA, Dunmore, Pennsylvania, United States
Magee Women's Hospital of UPMC, Pittsburgh, Pennsylvania, United States
Associates in Hematolog-Oncology, P.C., Upland, Pennsylvania, United States
Carolina Center of Gynecologic Oncology, Charleston, South Carolina, United States
Palmetto Health Alliance-Richland, Columbia, South Carolina, United States
South Carolina Oncology Associates, Columbia, South Carolina, United States
Arlington Cancer Center, Arlington, Texas, United States
Arlington Cancer Center, Trophy Club, Texas, United States
Danville Hematology & Oncology, Inc., Danville, Virginia, United States
Carilion GYN Oncology Associates, Roanoke, Virginia, United States
Algemeen Ziekenhuis Middelheim, Antwerpen, , Belgium
A.Z. Groeninge Oncologish Centrum, Kortrijk, , Belgium
Universitaire Ziekenhuizen Leuven Dienst Oncologie, Leuven, , Belgium
Hospital Vera Cruz-Instituto de Oncologia, Belo Horizonte, MG, Brazil
Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo, Cerqueria Cesar, Sao Paulo, Brazil
Fundacao Hospital Amaral Carvalho, Rua Dona Siilveria, Sao Paulo, Brazil
Guy's & St. Thomas Cancer Centre, London, England, United Kingdom
Ninewells Hospital and Medical School, Dundee, Scotland, United Kingdom
Contact Details
Name: Gail L. Brown, MD, MBA
Affiliation: Telik
Role: STUDY_DIRECTOR
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