Phase 3 Randomized Study of Telcyta + Doxorubicin Versus Doxorubicin in Platinum Refractory or Resistant Ovarian Cancer
NCT ID: NCT00350948
Last Updated: 2013-11-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE3
244 participants
INTERVENTIONAL
2006-05-31
2008-12-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Telcyta + Liposomal Doxorubicin
Telcyta at 1000 mg/m2 followed by Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Telcyta
Day 1 of 28 day Cycle.
Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Liposomal Doxorubicin
Liposomal Doxorubicin at 50 mg/m2 on Day 1 of each four-week treatment cycle
Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Interventions
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Telcyta
Day 1 of 28 day Cycle.
Liposomal Doxorubicin
Day 1 of 28 Day Cycle. 50 mg/m2
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
FEMALE
No
Sponsors
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Telik
INDUSTRY
Responsible Party
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Principal Investigators
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Gail L. Brown, MD, MBA
Role: STUDY_DIRECTOR
Telik
Locations
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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
Antwerp, , Belgium
A.Z. Groeninge Oncologish Centrum
Kortrijk, , Belgium
Universitaire Ziekenhuizen Leuven Dienst Oncologie
Leuven, , Belgium
Hospital Vera Cruz-Instituto de Oncologia
Belo Horizonte, Minas Gerais, Brazil
Centr de Oncologia do Instituto de Radiologia do Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo
Cerqueria Cesar, São Paulo, Brazil
Fundacao Hospital Amaral Carvalho
Rua Dona Siilveria, São Paulo, Brazil
Guy's & St. Thomas Cancer Centre
London, England, United Kingdom
Ninewells Hospital and Medical School
Dundee, Scotland, United Kingdom
Countries
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References
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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.
Vergote I, Finkler NJ, Hall JB, Melnyk O, Edwards RP, Jones M, Keck JG, Meng L, Brown GL, Rankin EM, Burke JJ, Boccia RV, Runowicz CD, Rose PG. Randomized phase III study of canfosfamide in combination with pegylated liposomal doxorubicin compared with pegylated liposomal doxorubicin alone in platinum-resistant ovarian cancer. Int J Gynecol Cancer. 2010 Jul;20(5):772-80. doi: 10.1111/igc.0b013e3181daaf59.
Other Identifiers
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TLK286.3025
Identifier Type: -
Identifier Source: org_study_id