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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT00262990
First received: December 6, 2005
Last updated: May 2, 2012
Last verified: May 2012
  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.


Condition Intervention Phase
Ovarian Cancer
Fallopian Tube Cancer
Peritoneal Neoplasms
Drug: EPO906 (Patupilone)
Drug: doxorubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • To 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 ]

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 ]

Enrollment: 829
Study Start Date: November 2005
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Patupilone Drug: EPO906 (Patupilone)
Other Name: Patupilone
Active Comparator: doxorubicin Drug: doxorubicin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00262990

  Hide Study Locations
Locations
United States, Alaska
Alaska Cancer Research & Education Center
Anchorage, Alaska, United States, 99508
United States, Arizona
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
United States, Arkansas
Genesis Cancer Center
Hot Springs, Arkansas, United States, 71913
University of Arkansas for Medical Sciences
Little Rock, Arkansas, United States, 72205
United States, California
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
United States, Colorado
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
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
United States, Delaware
Christiana Gynecologic Oncology, LLC
Newark, Delaware, United States, 19713
United States, District of Columbia
Washington Hospital Center/Medstar Research Institute
Washington, District of Columbia, United States, 20010-2931
United States, Florida
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
United States, Georgia
Medical College of Georgia
Augusta, Georgia, United States, 30912
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Hawaii
Kapiolani Medical Center for Women and Children/Univ. of HI
Honolulu, Hawaii, United States, 96826
United States, Illinois
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
United States, Indiana
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
United States, Kentucky
Louisville Oncology
Louisville, Kentucky, United States, 40202
United States, Maryland
Franklin Square Hospital Center
Baltimore, Maryland, United States, 21237
United States, Massachusetts
Boston University Medical Center Hospital
Boston, Massachusetts, United States, 02118
United States, Michigan
Providence Cancer Center
Southfield, Michigan, United States, 48075
United States, Minnesota
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
United States, Mississippi
The West Clinic
Corinth, Mississippi, United States, 38834
The West Clinic
Southaven, Mississippi, United States, 38671
United States, Missouri
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
United States, Nebraska
Southeast Nebraska Oncology/Southeast Nebraska Cancer Center
Lincoln, Nebraska, United States, 68510
United States, Nevada
Comprehensive Cancer Centers of Nevada
Las Vegas, Nevada, United States, 89109
Women's Cancer Center of Nevada
Las Vegas, Nevada, United States, 89109
United States, New Hampshire
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
United States, New Jersey
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
United States, New York
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
United States, North Carolina
Brody School of Medicine
Greenville, North Carolina, United States, 27834
New Hanover Regional Medical Center/Zimmer Cancer Center
Wilmington, North Carolina, United States, 28401
United States, Ohio
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
United States, Oklahoma
Cancer Care Associates
Tulsa, Oklahoma, United States, 74136
United States, Oregon
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
United States, Pennsylvania
Medical Oncology Associates of Wyoming Valley, PC
Kingston, Pennsylvania, United States, 18704
Magee - Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
GYN Oncology Research/Gynecologic Oncology Research & Development, LLC
Greenville, South Carolina, United States, 29601
United States, Tennessee
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
United States, Texas
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
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Vermont
Fletcher Allen Health Care
Burlington, Vermont, United States, 05401
United States, Virginia
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
United States, Washington
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
United States, Wisconsin
Aurora Medical Gyn Group
West Allis, Wisconsin, United States, 53227
Australia
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
Canada, British Columbia
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada
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
Denmark
Novartis Investigative Site
Odense, Denmark
Novartis Investigative Site
Vejle, Denmark
Finland
Novartis Investigative Site
Helsinki, Finland
Novartis Investigative Site
Kuopio, Finland
Novartis Investigative Site
Tampere, Finland
France
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
Greece
Novartis Investigative Site
Athens, Greece
Italy
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
Poland
Novartis Investigative Site
Krakow, Poland
South Africa
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
Spain
Novartis Investigative Site
Barcelona, Spain
Novartis Investigative Site
Madrid, Spain
United Kingdom
Novartis Investigative Site
Glasgow, United Kingdom
Novartis Investigative Site
London, United Kingdom
Novartis Investigative Site
Wirral, United Kingdom
Novartis Investigative Site
Wolverhampton, United Kingdom
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Additional Information:
No publications provided by Novartis

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00262990     History of Changes
Other Study ID Numbers: CEPO906A2303
Study First Received: December 6, 2005
Last Updated: May 2, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Epithelial ovarian cancer
fallopian tube cancer
peritoneal cancer
primary cancer
recurrent cancer
doxorubicin
taxane chemotherapy
platinum chemotherapy
Patupilone
taxane platinum resistant

Additional relevant MeSH terms:
Neoplasms
Ovarian Neoplasms
Peritoneal Neoplasms
Fallopian Tube Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Genital Neoplasms, Female
Urogenital Neoplasms
Endocrine System Diseases
Gonadal Disorders
Abdominal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Peritoneal Diseases
Fallopian Tube Diseases
Doxorubicin
Liposomal doxorubicin
Epothilone B
Epothilones
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014