Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
- Registration Number
- NCT00350948
- Lead Sponsor
- Telik
- 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).
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 244
- Are a woman 18 years of age or older
- Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
- Have platinum refractory or resistant cancer
- Measurable disease according to radiographic RECIST criteria progression
- Had treatment with first-line chemotherapy other than a platinum-containing regimen
- Have clinically significant cardiac disease
- Have any sign of intestinal obstruction interfering with nutrition
- Are pregnant or lactating
- Had prior treatment with liposomal doxorubicin
- Had prior treatment with Telcyta
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telcyta + Liposomal Doxorubicin Telcyta Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle Telcyta + Liposomal Doxorubicin Liposomal Doxorubicin Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle Liposomal Doxorubicin Liposomal Doxorubicin Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
- Primary Outcome Measures
Name Time Method To demonstrate superiority in progression-free survival of TLK286 in combination with liposomal doxorubicin as compared with the active control arm liposomal doxorubicin Once 244 planned pts. received at least 2 cycles of study treatment(s)
- Secondary Outcome Measures
Name Time Method To evaluate and compare the safety profile of each treatment arm Any patient who received 1 dose of study treatment(s) will be evaluable for safety.
Trial Locations
- Locations (68)
Desert Hematology Oncology Medical Group
🇺🇸Rancho Mirage, California, United States
Gynecologic Oncology Associates, Inc
🇺🇸Pembroke Pines, Florida, United States
Memorial Health University Medical Center
🇺🇸Savannah, Georgia, United States
Palmetto Health Alliance-Richland
🇺🇸Columbia, South Carolina, United States
South Carolina Oncology Associates
🇺🇸Columbia, South Carolina, United States
Guy's & St. Thomas Cancer Centre
🇬🇧London, England, United Kingdom
Women's Cancer Research Foundation
🇺🇸Newport Beach, California, United States
East Bay Medical Oncology/Hematology Medical Associates
🇺🇸Concord, California, United States
California Oncology of the Central Valley
🇺🇸Fresno, California, United States
Desert Oasis Cancer Center
🇺🇸Casa Grande, Arizona, United States
Piedmont Hematology Oncology Associates-Lexington Satellite
🇺🇸Lexington, North Carolina, United States
Hope A Women's Cancer Center
🇺🇸Asheville, North Carolina, United States
Ninewells Hospital and Medical School
🇬🇧Dundee, Scotland, United Kingdom
Presbyterian Hospital
🇺🇸Charlotte, North Carolina, United States
Associates in Hematolog-Oncology, P.C.
🇺🇸Upland, Pennsylvania, United States
St. Vincent Gynecologic Oncology
🇺🇸Indianapolis, Indiana, United States
Kaiser Permanente Moanalua Medical Center
🇺🇸Honolulu, Hawaii, United States
Dakota Cancer Institute/Dakota Clinic Ltd.
🇺🇸Fargo, North Dakota, United States
Abington Memorial Hospital
🇺🇸Abington, Pennsylvania, 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
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
Center for Cancer and Blood Disorders
🇺🇸Bethesda, Maryland, United States
Hematology & Oncology Consultants P.C.
🇺🇸Omaha, Nebraska, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
East Bay Medical Oncology/Hematology Medical Associates, Inc.
🇺🇸Antioch, California, United States
Southwest Cancer Care
🇺🇸Poway, California, United States
Diablo Valley Oncology & Hematology Medical Group, Inc.
🇺🇸Walnut Creek, California, United States
Joliet Oncology-Hematology Associates
🇺🇸Morris, Illinois, United States
Flossmoor Cancer Care (JOHA DBA)
🇺🇸Flossmoor, Illinois, United States
Central Baptist Hospital
🇺🇸Lexington, Kentucky, United States
Hematology and Oncology Specialists, LLC
🇺🇸Metairie, Louisiana, United States
Arch Medical Services
🇺🇸St. Louis, Missouri, United States
The Women's Center of Western Nebraska
🇺🇸Scottsbluff, Nebraska, United States
Monter Cancer Center
🇺🇸Lake Success, New York, United States
The Mary Imogene Bassett Hospital
🇺🇸Cooperstown, New York, United States
Long Island Jewish Medical Center
🇺🇸New Hyde Park, New York, United States
Blumenthal Cancer Center
🇺🇸Charlotte, North Carolina, United States
Piedmont Hematology Oncology Associates
🇺🇸Winston Salem, North Carolina, United States
Garth Phibbs, M.D., FACOG
🇺🇸Toledo, Ohio, United States
The Toledo Hospital
🇺🇸Toledo, Ohio, United States
Gynecologic Oncology & Pelvic Surgery Associates
🇺🇸Columbus, Ohio, United States
Kaiser Permanente NW, Oncology/Hematology
🇺🇸Portland, Oregon, United States
Danville Hematology & Oncology, Inc.
🇺🇸Danville, Virginia, United States
Arlington Cancer Center
🇺🇸Trophy Club, Texas, United States
Algemeen Ziekenhuis Middelheim
🇧🇪Antwerpen, Belgium
Carilion GYN Oncology Associates
🇺🇸Roanoke, Virginia, United States
Hospital Vera Cruz-Instituto de Oncologia
🇧🇷Belo Horizonte, MG, Brazil
A.Z. Groeninge Oncologish Centrum
🇧🇪Kortrijk, Belgium
Fundacao Hospital Amaral Carvalho
🇧🇷Rua Dona Siilveria, Sao Paulo, Brazil
Bay Area Cancer Research Group, LLC
🇺🇸Concord, California, United States
Shands Jacksonville Medical Center
🇺🇸Jacksonville, Florida, United States
Joliet Oncology-Hematology Associates, LTD.
🇺🇸Joliet, Illinois, United States
University of Florida College of Medicine-Jacksonville
🇺🇸Jacksonville, Florida, United States
Schwaartz Gynecologic Oncology, PLLC
🇺🇸Babylon, New York, United States
Kankakee Cancer Center (JOHA DBA)
🇺🇸Kankakee, Illinois, United States
Magee Women's Hospital of UPMC
🇺🇸Pittsburgh, Pennsylvania, United States
Carolinas Medical Center
🇺🇸Charlotte, North Carolina, United States
Hematology & Oncology Associates of NEPA
🇺🇸Dunmore, Pennsylvania, United States
LSU Health Sciences Center
🇺🇸Shreveport, Louisiana, United States
Hematology Oncology Services of Arkansas
🇺🇸Little Rock, Arkansas, United States
Universitaire Ziekenhuizen Leuven Dienst Oncologie
🇧🇪Leuven, Belgium
University of Arkansas for Medical Sciences
🇺🇸Little Rock, Arkansas, United States
North Shore University Hospital
🇺🇸Manhasset, New York, United States
Horizon's West Medical Group
🇺🇸Scottsbluff, Nebraska, United States
Florida Hospital Cancer Institute
🇺🇸Orlando, Florida, United States
Florida Hospital
🇺🇸Orlando, Florida, United States
Carolina Center of Gynecologic Oncology
🇺🇸Charleston, South Carolina, United States