Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

Overview[ - collapse ][ - ]

Purpose 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.
ConditionOvarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
InterventionDrug: EPO906 (Patupilone)
Drug: doxorubicin
PhasePhase 3
SponsorNovartis Pharmaceuticals
Responsible PartyNovartis
ClinicalTrials.gov IdentifierNCT00262990
First ReceivedDecember 6, 2005
Last UpdatedMay 2, 2012
Last verifiedMay 2012

Tracking Information[ + expand ][ + ]

First Received DateDecember 6, 2005
Last Updated DateMay 2, 2012
Start DateNovember 2005
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresTo show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer [Time Frame: every 8 weeks] [Designated as safety issue: No]
Current Secondary Outcome Measures
  • To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD) [Time Frame: End of study] [Designated as safety issue: No]
  • To determine the progression-free survival (PFS) of patients treated with patupilone [Time Frame: end of study] [Designated as safety issue: No]
  • To determine the time to disease progression (TTP) of patients treated with patupilone [Time Frame: end of study] [Designated as safety issue: No]
  • To determine overall best tumor response (CR, PR, SD, PD and Unknown) [Time Frame: end of study] [Designated as safety issue: No]
  • To investigate the safety and tolerability of patupilone [Time Frame: end of study] [Designated as safety issue: Yes]
  • To evaluate the pharmacokinetics (PK) of patupilone from all patients [Time Frame: end of study] [Designated as safety issue: No]
  • To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events [Time Frame: end of study] [Designated as safety issue: Yes]

Descriptive Information[ + expand ][ + ]

Brief TitlePatupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer
Official TitleA 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
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition
  • Ovarian Cancer
  • Fallopian Tube Cancer
  • Peritoneal Neoplasms
InterventionDrug: EPO906 (Patupilone)
Other Names:
PatupiloneDrug: doxorubicin
Study Arm (s)
  • Experimental: Patupilone
  • Active Comparator: doxorubicin

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment829
Estimated Completion DateNot Provided
Estimated Primary Completion DateFebruary 2010
Eligibility Criteria
Inclusion Criteria:

- 18 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

Exclusion Criteria:

- Have an unresolved bowel obstruction

- Have had previous chemotherapy within 3 weeks

- Recovering from any surgery for any cause

Other protocol-defined inclusion/exclusion criteria will apply.
GenderFemale
Ages18 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States, Australia, Canada, Denmark, Finland, France, Greece, Italy, Poland, South Africa, Spain, United Kingdom

Administrative Information[ + expand ][ + ]

NCT Number NCT00262990
Other Study ID NumbersCEPO906A2303
Has Data Monitoring CommitteeNot Provided
Information Provided ByNovartis
Study SponsorNovartis Pharmaceuticals
CollaboratorsNot Provided
Investigators Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Verification DateMay 2012

Locations[ + expand ][ + ]

Alaska Cancer Research & Education Center
Anchorage, Alaska, United States, 99508
Northern Arizona Hematology & Oncology Associates
Flagstaff, Arizona, United States, 86001
Mayo Center for Women's Health
Scottsdale, Arizona, United States, 85259
Northern Arizona Hematology & Oncology Associates
Sedona, Arizona, United States, 86336
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
Yanagihara, Ronald H.
Gilroy, California, United States, 95020
California Cancer Care, Inc.
Greenbrae, California, United States, 94904
University of California - San Diego/ Moores Cancer Center
La Jolla, California, United States, 92093-0987
LAC & USC Women's & Children's Hospital
Los Angeles, California, United States, 90033
Gynecologic Oncology associates
Newport Beach, California, United States, 92663
UC Davis Cancer Center
Sacramento, California, United States, 95817
California Pacific Medical Center Research Institute
San Francisco, California, United States, 94115
Anschutz Cancer Pavilion
Aurora, Colorado, United States, 80045
Anschutz Cancer Pavilion - Clinical Investigations Core
Aurora, Colorado, United States, 90045
University Of Colorado Health Sciences Center
Denver, Colorado, United States, 80262
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Christiana Gynecologic Oncology, LLC
Newark, Delaware, United States, 19713
Washington Hospital Center/Medstar Research Institute
Washington, District of Columbia, United States, 20010-2931
Florida Gynecologic Oncology
Fort Myers, Florida, United States, 33901
Miami Cancer Center at Mercy Hospital
Miami, Florida, United States, 33133
Advanced Medical Specialties
Miami, Florida, United States, 33176
University of Miami
Miami, Florida, United States, 33136
Mt. Sinai Medical Center
Miami, Florida, United States, 33143
Miami Cancer Center at University Hospital
Miami, Florida, United States, 33133
Ocala Oncology Center
Ocala, Florida, United States, 34471
MD Anderson Cancer Center of Orlando
Orlando, Florida, United States, 32806
Oncology & Hematology Associates of West Broward
Tamarac, Florida, United States, 33321
Xelero Medical Research/Giselle Ghurani
Tampa, Florida, United States, 33607
Medical College of Georgia
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
Kapiolani Medical Center for Women and Children/Univ. of HI
Honolulu, Hawaii, United States, 96826
Rush University Medical Center
Chicago, Illinois, United States, 60612
Northwest Memorial Hospital
Chicago, Illinois, United States, 60611
Cancer Institute of Central Illinois/Decatur Memorial Hospital
Decatur, Illinois, United States, 62526
Indiana University Obstetrics
Indianapolis, Indiana, United States, 00144
Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation
Indianapolis, Indiana, United States, 46267
Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center
Indianapolis, Indiana, United States, 46202
Northern Indiana Cancer Research Consortium
South Bend, Indiana, United States, 46617
Louisville Oncology
Louisville, Kentucky, United States, 40202
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
Boston University Medical Center Hospital
Boston, Massachusetts, United States, 02118
Providence Cancer Center
Southfield, Michigan, United States, 48075
Minnesota Oncology/Hematology, PA
Burnsville, Minnesota, United States, 55337
St. Luke's Hospital
Duluth, Minnesota, United States, 55805
Minnesota Oncology/Hematology, PA
Edina, Minnesota, United States, 55435
Minnesota Oncology/Hematology Associates of Central Illinois
Minneapolis, Minnesota, United States, 55404
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Metro-MN CCOP
St. Louis Park, Minnesota, United States, 55416
Minnesota Oncology Hematology
St. Paul, Minnesota, United States, 55102-2389
The West Clinic
Corinth, Mississippi, United States, 38834
The West Clinic
Southaven, Mississippi, United States, 38671
St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute
Kansas City, Missouri, United States, 64111
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89109
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
Hematology and Oncology Associates of Northern New Jersey
Morristown, New Jersey, United States, 07962
University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey
New Brunswick, New Jersey, United States, 07090
New York Oncology Hematology, P.C.
Albany, New York, United States, 12208
Schwartz Gynecologic Oncology, PLLC
Babylon, New York, United States, 11702
Bellview Hospital
New York, New York, United States, 10016
NYU Cancer Institute
New York, New York, United States, 10016
New York University School of Medicine/NYU Cancer Institute
New York, New York, United States, 10016
St. Vincent Catholic Medical Center of New York
Staten Island, New York, United States, 10310
Brody School of Medicine
Greenville, North Carolina, United States, 27834
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, United States, 28401
Ohio State University Medical Center
Columbus, Ohio, United States, 43210-1228
Camelot Women's Cancer
Columbus, Ohio, United States, 43214
The Arthur G. James Cancer Hospital
Columbus, Ohio, United States, 43214
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center
Eugene, Oregon, United States, 97401-8122
Northwest Cancer Specialists, P.C.
Portland, Oregon, United States, 97227
Willamette Valley Cancer Center
Springfield, Oregon, United States, 97477
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
Magee - Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, United States, 29601
Chattanooga GYN Oncology
Chattanooga, Tennessee, United States, 37403
Hall and Martin MDs, PC
Knoxville, Tennessee, United States, 37920
West Clinic
Memphis, Tennessee, United States, 38120
The West Clinic
Memphis, Tennessee, United States, 38104
Texas Oncology
Austin, Texas, United States, 78745
Texas Oncology, P.A.
Austin, Texas, United States, 78731
Texas Oncology, P.A.
Bedford, Texas, United States, 76022
Sammons Cancer Center
Dallas, Texas, United States, 75246
Texas Oncology, P.A.
Dallas, Texas, United States, 75231
Texas Oncology, P.A.
Dallas, Texas, United States, 75246
Texas Oncology, P.A.
Fort Worth, Texas, United States, 76104
Oncology Consultants P.A.
Houston, Texas, United States, 77024
Cancer Care Center of South Texas
San Antonio, Texas, United States, 78229
Waco Cancer Care & Research Center
Waco, Texas, United States, 76712
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
Cancer Outreach Associates
Abingdon, Virginia, United States, 24211
Northern Virginia Pelvic Surgery Associates
Annandale, Virginia, United States, 22003
Virginia Oncology Associates
Newport News, Virginia, United States, 23606
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Commonwealth University/VCU Massey Cancer Center
Richmond, Virginia, United States, 23298
Gersh, Robert
Spokane, Washington, United States, 99202
Northwest Cancer Specialists
Vancouver, Washington, United States, 98664
Northwest Cancer Specialists, P.C.
Vancouver, Washington, United States, 98664
Yakima Valley Memorial Hospital
Yakima, Washington, United States, 98902
Aurora Medical Gyn Group
West Allis, Wisconsin, United States, 53227
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, Canada, V5Z 4E6
Novartis Investigative Site
Calgary, Canada
Novartis Investigative Site
Montreal, Canada
Novartis Investigative Site
North York, Canada
Novartis Investigative Site
Quebec, Canada
Novartis Investigative Site
Sherbrooke, Canada
Novartis Investigative Site
Toronto, Canada, M5G 2M9
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 Cedex, France
Novartis Investigative Site
Herblain Cedec, France
Novartis Investigative Site
Villejuif Cedex, France
Novartis Investigative Site
Athens, Greece
Novartis Investigative Site
Bologna, Italy
Novartis Investigative Site
Milano, Italy
Novartis Investigative Site
Modena, Italy
Novartis Investigative Site
Monza, Italy
Novartis Investigative Site
Padova, 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
Wirral, United Kingdom
Novartis Investigative Site
Wolverhampton, United Kingdom