Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer
1 other identifier
interventional
829
12 countries
149
Brief Summary
The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 ovarian-cancer
149 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2005
CompletedFirst Submitted
Initial submission to the registry
December 6, 2005
CompletedFirst Posted
Study publicly available on registry
December 7, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedDecember 17, 2020
May 1, 2012
4.3 years
December 6, 2005
December 11, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer
every 8 weeks
Secondary Outcomes (7)
To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)
End of study
To determine the progression-free survival (PFS) of patients treated with patupilone
end of study
To determine the time to disease progression (TTP) of patients treated with patupilone
end of study
To determine overall best tumor response (CR, PR, SD, PD and Unknown)
end of study
To investigate the safety and tolerability of patupilone
end of study
- +2 more secondary outcomes
Study Arms (2)
Patupilone
EXPERIMENTALdoxorubicin
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- years of age or older
- Confirmed diagnosis of ovarian, fallopian or peritoneal cancer
- No more than three chemotherapy regimens
- Most recent regimen must have been platinum based
You may not qualify if:
- Have an unresolved bowel obstruction
- Have had previous chemotherapy within 3 weeks
- Recovering from any surgery for any cause
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (149)
Alaska Cancer Research & Education Center
Anchorage, Alaska, 99508, United States
Northern Arizona Hematology & Oncology Associates
Flagstaff, Arizona, 86001, United States
Mayo Center for Women's Health
Scottsdale, Arizona, 85259, United States
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, 86336, United States
Genesis Cancer Center
Hot Springs, Arkansas, 71913, United States
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205, United States
Yanagihara, Ronald H.
Gilroy, California, 95020, United States
California Cancer Care, Inc.
Greenbrae, California, 94904, United States
University of California - San Diego/ Moores Cancer Center
La Jolla, California, 92093-0987, United States
LAC & USC Women's & Children's Hospital
Los Angeles, California, 90033, United States
Gynecologic Oncology associates
Newport Beach, California, 92663, United States
UC Davis Cancer Center
Sacramento, California, 95817, United States
California Pacific Medical Center Research Institute
San Francisco, California, 94115, United States
Anschutz Cancer Pavilion
Aurora, Colorado, 80045, United States
Anschutz Cancer Pavilion - Clinical Investigations Core
Aurora, Colorado, 90045, United States
University Of Colorado Health Sciences Center
Denver, Colorado, 80262, United States
Yale University School of Medicine
New Haven, Connecticut, 06520, United States
Christiana Gynecologic Oncology, LLC
Newark, Delaware, 19713, United States
Washington Hospital Center/Medstar Research Institute
Washington D.C., District of Columbia, 20010-2931, United States
Florida Gynecologic Oncology
Fort Myers, Florida, 33901, United States
Miami Cancer Center at Mercy Hospital
Miami, Florida, 33133, United States
Miami Cancer Center at University Hospital
Miami, Florida, 33133, United States
University of Miami
Miami, Florida, 33136, United States
Mt. Sinai Medical Center
Miami, Florida, 33143, United States
Advanced Medical Specialties
Miami, Florida, 33176, United States
Ocala Oncology Center
Ocala, Florida, 34471, United States
MD Anderson Cancer Center of Orlando
Orlando, Florida, 32806, United States
Oncology & Hematology Associates of West Broward
Tamarac, Florida, 33321, United States
Xelero Medical Research/Giselle Ghurani
Tampa, Florida, 33607, United States
Medical College of Georgia
Augusta, Georgia, 30912, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
Kapiolani Medical Center for Women and Children/Univ. of HI
Honolulu, Hawaii, 96826, United States
Northwest Memorial Hospital
Chicago, Illinois, 60611, United States
Rush University Medical Center
Chicago, Illinois, 60612, United States
Cancer Institute of Central Illinois/Decatur Memorial Hospital
Decatur, Illinois, 62526, United States
Indiana University Obstetrics
Indianapolis, Indiana, 00144, United States
Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, 46202, United States
Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation
Indianapolis, Indiana, 46267, United States
Northern Indiana Cancer Research Consortium
South Bend, Indiana, 46617, United States
Louisville Oncology
Louisville, Kentucky, 40202, United States
Franklin Square Hospital Center
Baltimore, Maryland, 21237, United States
Boston University Medical Center Hospital
Boston, Massachusetts, 02118, United States
Providence Cancer Center
Southfield, Michigan, 48075, United States
Minnesota Oncology/Hematology, PA
Burnsville, Minnesota, 55337, United States
St. Luke's Hospital
Duluth, Minnesota, 55805, United States
Minnesota Oncology/Hematology, PA
Edina, Minnesota, 55435, United States
Minnesota Oncology/Hematology Associates of Central Illinois
Minneapolis, Minnesota, 55404, United States
University of Minnesota
Minneapolis, Minnesota, 55455, United States
Metro-MN CCOP
Saint Louis Park, Minnesota, 55416, United States
Minnesota Oncology Hematology
Saint Paul, Minnesota, 55102-2389, United States
The West Clinic
Corinth, Mississippi, 38834, United States
The West Clinic
Southaven, Mississippi, 38671, United States
St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute
Kansas City, Missouri, 64111, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
Lincoln, Nebraska, 68510, United States
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, 89109, United States
Women's Cancer Center of Nevada
Las Vegas, Nevada, 89109, United States
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, 03756, United States
Hematology and Oncology Associates of Northern New Jersey
Morristown, New Jersey, 07962, United States
University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey
New Brunswick, New Jersey, 07090, United States
New York Oncology Hematology, P.C.
Albany, New York, 12208, United States
Schwartz Gynecologic Oncology, PLLC
Babylon, New York, 11702, United States
Bellview Hospital
New York, New York, 10016, United States
New York University School of Medicine/NYU Cancer Institute
New York, New York, 10016, United States
NYU Cancer Institute
New York, New York, 10016, United States
St. Vincent Catholic Medical Center of New York
Staten Island, New York, 10310, United States
Brody School of Medicine
Greenville, North Carolina, 27834, United States
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, 28401, United States
Ohio State University Medical Center
Columbus, Ohio, 43210-1228, United States
Camelot Women's Cancer
Columbus, Ohio, 43214, United States
The Arthur G. James Cancer Hospital
Columbus, Ohio, 43214, United States
Cancer Care Associates
Tulsa, Oklahoma, 74136, United States
Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center
Eugene, Oregon, 97401-8122, United States
Northwest Cancer Specialists, P.C.
Portland, Oregon, 97227, United States
Willamette Valley Cancer Center
Springfield, Oregon, 97477, United States
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, 18704, United States
Magee - Women's Hospital
Pittsburgh, Pennsylvania, 15213, United States
GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, 29601, United States
Chattanooga GYN Oncology
Chattanooga, Tennessee, 37403, United States
Hall and Martin MDs, PC
Knoxville, Tennessee, 37920, United States
The West Clinic
Memphis, Tennessee, 38104, United States
West Clinic
Memphis, Tennessee, 38120, United States
Texas Oncology, P.A.
Austin, Texas, 78731, United States
Texas Oncology
Austin, Texas, 78745, United States
Texas Oncology, P.A.
Bedford, Texas, 76022, United States
Texas Oncology, P.A.
Dallas, Texas, 75231, United States
Sammons Cancer Center
Dallas, Texas, 75246, United States
Texas Oncology, P.A.
Dallas, Texas, 75246, United States
Texas Oncology, P.A.
Fort Worth, Texas, 76104, United States
Oncology Consultants P.A.
Houston, Texas, 77024, United States
Cancer Care Center of South Texas
San Antonio, Texas, 78229, United States
Waco Cancer Care & Research Center
Waco, Texas, 76712, United States
Utah Cancer Specialists
Salt Lake City, Utah, 84106, United States
Fletcher Allen Health Care
Burlington, Vermont, 05401, United States
Cancer Outreach Associates
Abingdon, Virginia, 24211, United States
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, 22003, United States
Virginia Oncology Associates
Newport News, Virginia, 23606, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
Virginia Commonwealth University/VCU Massey Cancer Center
Richmond, Virginia, 23298, United States
Gersh, Robert
Spokane, Washington, 99202, United States
Northwest Cancer Specialists, P.C.
Vancouver, Washington, 98664, United States
Northwest Cancer Specialists
Vancouver, Washington, 98664, United States
Yakima Valley Memorial Hospital
Yakima, Washington, 98902, United States
Aurora Medical Gyn Group
West Allis, Wisconsin, 53227, United States
Novartis Investigative Site
Adelaide, Australia
Novartis Investigative Site
Herston, Australia
Novartis Investigative Site
Nedlands, WA, Australia
Novartis Investigative Site
South Brisbane, Australia
Novartis Investigative Site
St Leonards, Australia
Novartis Investigative Site
Wodonga, Australia
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Novartis Investigative Site
Calgary, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
North York, Canada
Novartis Investigative Site
Québec, Canada
Novartis Investigative Site
Sherbrooke, Canada
Novartis Investigative Site
Toronto, M5G 2M9, Canada
Novartis Investigative Site
Odense, Denmark
Novartis Investigative Site
Vejle, Denmark
Novartis Investigative Site
Helsinki, Finland
Novartis Investigative Site
Kuopio, Finland
Novartis Investigative Site
Tampere, Finland
Novartis Investigative Site
Amboise, France
Novartis Investigative Site
Bordeaux, France
Novartis Investigative Site
Caen, France
Novartis Investigative Site
Herblain Cedec, France
Novartis Investigative Site
Villejuif, France
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Bologna, Italy
Novartis Investigative Site
Milan, Italy
Novartis Investigative Site
Modena, Italy
Novartis Investigative Site
Monza, Italy
Novartis Investigative Site
Padua, Italy
Novartis Investigative Site
Roma, Italy
Novartis Investigative Site
Torino, Italy
Novartis Investigative Site
Krakow, Poland
Novartis Investigative Site
Cape Town, South Africa
Novartis Investigative Site
Johannesburg, Gauteng, South Africa
Novartis Investigative Site
Klerksdorp, South Africa
Novartis Investigative Site
Port Elizabeth, South Africa
Novartis Investigative Site
Pretoria, Gauteng, South Africa
Novartis Investigative Site
Pretoria, Guateng, South Africa
Novartis Investigative Site
Sandton, Gauteng, South Africa
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
Novartis Investigative Site
Glasgow, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Metropolitan Borough of Wirral, United Kingdom
Novartis Investigative Site
Wolverhampton, United Kingdom
Related Publications (2)
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.
PMID: 37407274DERIVEDColombo N, Kutarska E, Dimopoulos M, Bae DS, Rzepka-Gorska I, Bidzinski M, Scambia G, Engelholm SA, Joly F, Weber D, El-Hashimy M, Li J, Souami F, Wing P, Engelholm S, Bamias A, Schwartz P. Randomized, open-label, phase III study comparing patupilone (EPO906) with pegylated liposomal doxorubicin in platinum-refractory or -resistant patients with recurrent epithelial ovarian, primary fallopian tube, or primary peritoneal cancer. J Clin Oncol. 2012 Nov 1;30(31):3841-7. doi: 10.1200/JCO.2011.38.8082. Epub 2012 Sep 17.
PMID: 22987083DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2005
First Posted
December 7, 2005
Study Start
November 1, 2005
Primary Completion
February 1, 2010
Last Updated
December 17, 2020
Record last verified: 2012-05