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

Last updated: December 11, 2020
Sponsor: Novartis Pharmaceuticals
Overall Status: Completed

Phase

3

Condition

Ovarian Cancer

Malignant Ascites

Digestive System Neoplasms

Treatment

doxorubicin

EPO906 (Patupilone)

Clinical Study ID

NCT00262990
CEPO906A2303
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

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.

Study Design

Total Participants: 829
Treatment Group(s): 2
Primary Treatment: doxorubicin
Phase: 3
Study Start date:
November 01, 2005
Estimated Completion Date:

Connect with a study center

  • Novartis Investigative Site

    Adelaide,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Herston,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Nedlands, WA,
    Australia

    Site Not Available

  • Novartis Investigative Site

    South Brisbane,
    Australia

    Site Not Available

  • Novartis Investigative Site

    St. Leonards,
    Australia

    Site Not Available

  • Novartis Investigative Site

    Wodonga,
    Australia

    Site Not Available

  • BC Cancer Agency

    Vancouver, British Columbia V5Z 4E6
    Canada

    Site Not Available

  • Novartis Investigative Site

    Calgary,
    Canada

    Site Not Available

  • Novartis Investigative Site

    Montreal,
    Canada

    Site Not Available

  • Novartis Investigative Site

    North York,
    Canada

    Site Not Available

  • Novartis Investigative Site

    Quebec,
    Canada

    Site Not Available

  • Novartis Investigative Site

    Sherbrooke,
    Canada

    Site Not Available

  • Novartis Investigative Site

    Toronto, M5G 2M9
    Canada

    Site Not Available

  • Novartis Investigative Site

    Odense,
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Vejle,
    Denmark

    Site Not Available

  • Novartis Investigative Site

    Helsinki,
    Finland

    Site Not Available

  • Novartis Investigative Site

    Kuopio,
    Finland

    Site Not Available

  • Novartis Investigative Site

    Tampere,
    Finland

    Site Not Available

  • Novartis Investigative Site

    Amboise,
    France

    Site Not Available

  • Novartis Investigative Site

    Bordeaux,
    France

    Site Not Available

  • Novartis Investigative Site

    Caen Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Herblain Cedec,
    France

    Site Not Available

  • Novartis Investigative Site

    Villejuif Cedex,
    France

    Site Not Available

  • Novartis Investigative Site

    Athens,
    Greece

    Site Not Available

  • Novartis Investigative Site

    Bologna,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Milano,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Modena,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Monza,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Padova,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Roma,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Torino,
    Italy

    Site Not Available

  • Novartis Investigative Site

    Krakow,
    Poland

    Site Not Available

  • Novartis Investigative Site

    Cape Town,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Johannesburg, Gauteng,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Klerksdorp,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Port Elizabeth,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, Gauteng,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Pretoria, Guateng,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Sandton, Gauteng,
    South Africa

    Site Not Available

  • Novartis Investigative Site

    Barcelona,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Madrid,
    Spain

    Site Not Available

  • Novartis Investigative Site

    Glasgow,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    London,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Wirral,
    United Kingdom

    Site Not Available

  • Novartis Investigative Site

    Wolverhampton,
    United Kingdom

    Site Not Available

  • Alaska Cancer Research & Education Center

    Anchorage, Alaska 99508
    United States

    Site Not Available

  • Northern Arizona Hematology & Oncology Associates

    Flagstaff, Arizona 86001
    United States

    Site Not Available

  • Mayo Center for Women's Health

    Scottsdale, Arizona 85259
    United States

    Site Not Available

  • Northern Arizona Hematology & Oncology Associates

    Sedona, Arizona 86336
    United States

    Site Not Available

  • Genesis Cancer Center

    Hot Springs, Arkansas 71913
    United States

    Site Not Available

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Yanagihara, Ronald H.

    Gilroy, California 95020
    United States

    Site Not Available

  • California Cancer Care, Inc.

    Greenbrae, California 94904
    United States

    Site Not Available

  • University of California - San Diego/ Moores Cancer Center

    La Jolla, California 92093-0987
    United States

    Site Not Available

  • LAC & USC Women's & Children's Hospital

    Los Angeles, California 90033
    United States

    Site Not Available

  • Gynecologic Oncology associates

    Newport Beach, California 92663
    United States

    Site Not Available

  • UC Davis Cancer Center

    Sacramento, California 95817
    United States

    Site Not Available

  • California Pacific Medical Center Research Institute

    San Francisco, California 94115
    United States

    Site Not Available

  • Anschutz Cancer Pavilion

    Aurora, Colorado 80045
    United States

    Site Not Available

  • Anschutz Cancer Pavilion - Clinical Investigations Core

    Aurora, Colorado 90045
    United States

    Site Not Available

  • University Of Colorado Health Sciences Center

    Denver, Colorado 80262
    United States

    Site Not Available

  • Yale University School of Medicine

    New Haven, Connecticut 06520
    United States

    Site Not Available

  • Christiana Gynecologic Oncology, LLC

    Newark, Delaware 19713
    United States

    Site Not Available

  • Washington Hospital Center/Medstar Research Institute

    Washington, District of Columbia 20010-2931
    United States

    Site Not Available

  • Florida Gynecologic Oncology

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Advanced Medical Specialties

    Miami, Florida 33176
    United States

    Site Not Available

  • Miami Cancer Center at Mercy Hospital

    Miami, Florida 33133
    United States

    Site Not Available

  • Miami Cancer Center at University Hospital

    Miami, Florida 33133
    United States

    Site Not Available

  • Mt. Sinai Medical Center

    Miami, Florida 33143
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Ocala Oncology Center

    Ocala, Florida 34471
    United States

    Site Not Available

  • MD Anderson Cancer Center of Orlando

    Orlando, Florida 32806
    United States

    Site Not Available

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida 33321
    United States

    Site Not Available

  • Xelero Medical Research/Giselle Ghurani

    Tampa, Florida 33607
    United States

    Site Not Available

  • Medical College of Georgia

    Augusta, Georgia 30912
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Kapiolani Medical Center for Women and Children/Univ. of HI

    Honolulu, Hawaii 96826
    United States

    Site Not Available

  • Northwest Memorial Hospital

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Rush University Medical Center

    Chicago, Illinois 60612
    United States

    Site Not Available

  • Cancer Institute of Central Illinois/Decatur Memorial Hospital

    Decatur, Illinois 62526
    United States

    Site Not Available

  • Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation

    Indianapolis, Indiana 46267
    United States

    Site Not Available

  • Indiana University Cancer Center/Indiana UNiversity Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana 46202
    United States

    Site Not Available

  • Indiana University Obstetrics

    Indianapolis, Indiana 00144
    United States

    Site Not Available

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana 46617
    United States

    Site Not Available

  • Louisville Oncology

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Franklin Square Hospital Center

    Baltimore, Maryland 21237
    United States

    Site Not Available

  • Boston University Medical Center Hospital

    Boston, Massachusetts 02118
    United States

    Site Not Available

  • Providence Cancer Center

    Southfield, Michigan 48075
    United States

    Site Not Available

  • Minnesota Oncology/Hematology, PA

    Burnsville, Minnesota 55337
    United States

    Site Not Available

  • St. Luke's Hospital

    Duluth, Minnesota 55805
    United States

    Site Not Available

  • Minnesota Oncology/Hematology, PA

    Edina, Minnesota 55435
    United States

    Site Not Available

  • Minnesota Oncology/Hematology Associates of Central Illinois

    Minneapolis, Minnesota 55404
    United States

    Site Not Available

  • University of Minnesota

    Minneapolis, Minnesota 55455
    United States

    Site Not Available

  • Metro-MN CCOP

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota 55102-2389
    United States

    Site Not Available

  • Metro-MN CCOP

    St. Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Minnesota Oncology Hematology

    St. Paul, Minnesota 55102-2389
    United States

    Site Not Available

  • The West Clinic

    Corinth, Mississippi 38834
    United States

    Site Not Available

  • The West Clinic

    Southaven, Mississippi 38671
    United States

    Site Not Available

  • St. Luke's Hospital of Kansas City/St. Luke's Cancer Institute

    Kansas City, Missouri 64111
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University School of Medicine

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • Southeast Nebraska Oncology/Southeast Nebraska Cancer Center

    Lincoln, Nebraska 68510
    United States

    Site Not Available

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire 03756
    United States

    Site Not Available

  • Hematology and Oncology Associates of Northern New Jersey

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • University of Medicine and Dentistry of New Jersey/The Cancer Institute of Neew Jersey

    New Brunswick, New Jersey 07090
    United States

    Site Not Available

  • New York Oncology Hematology, P.C.

    Albany, New York 12208
    United States

    Site Not Available

  • Schwartz Gynecologic Oncology, PLLC

    Babylon, New York 11702
    United States

    Site Not Available

  • Bellview Hospital

    New York, New York 10016
    United States

    Site Not Available

  • NYU Cancer Institute

    New York, New York 10016
    United States

    Site Not Available

  • New York University School of Medicine/NYU Cancer Institute

    New York, New York 10016
    United States

    Site Not Available

  • St. Vincent Catholic Medical Center of New York

    Staten Island, New York 10310
    United States

    Site Not Available

  • Brody School of Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Camelot Women's Cancer

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Ohio State University Medical Center

    Columbus, Ohio 43210-1228
    United States

    Site Not Available

  • The Arthur G. James Cancer Hospital

    Columbus, Ohio 43214
    United States

    Site Not Available

  • Cancer Care Associates

    Tulsa, Oklahoma 74136
    United States

    Site Not Available

  • Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center

    Eugene, Oregon 97401-8122
    United States

    Site Not Available

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon 97227
    United States

    Site Not Available

  • Willamette Valley Cancer Center

    Springfield, Oregon 97477
    United States

    Site Not Available

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania 18704
    United States

    Site Not Available

  • Magee - Women's Hospital

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • GYN Oncology Research/Gynecologic Oncology Research & Development, LLC

    Greenville, South Carolina 29601
    United States

    Site Not Available

  • Chattanooga GYN Oncology

    Chattanooga, Tennessee 37403
    United States

    Site Not Available

  • Hall and Martin MDs, PC

    Knoxville, Tennessee 37920
    United States

    Site Not Available

  • The West Clinic

    Memphis, Tennessee 38104
    United States

    Site Not Available

  • West Clinic

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • Texas Oncology

    Austin, Texas 78745
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Austin, Texas 78731
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Bedford, Texas 76022
    United States

    Site Not Available

  • Sammons Cancer Center

    Dallas, Texas 75246
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Dallas, Texas 75231
    United States

    Site Not Available

  • Texas Oncology, P.A.

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Oncology Consultants P.A.

    Houston, Texas 77024
    United States

    Site Not Available

  • Cancer Care Center of South Texas

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Waco Cancer Care & Research Center

    Waco, Texas 76712
    United States

    Site Not Available

  • Utah Cancer Specialists

    Salt Lake City, Utah 84106
    United States

    Site Not Available

  • Fletcher Allen Health Care

    Burlington, Vermont 05401
    United States

    Site Not Available

  • Cancer Outreach Associates

    Abingdon, Virginia 24211
    United States

    Site Not Available

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia 22003
    United States

    Site Not Available

  • Virginia Oncology Associates

    Newport News, Virginia 23606
    United States

    Site Not Available

  • Virginia Oncology Associates

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Virginia Commonwealth University/VCU Massey Cancer Center

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Gersh, Robert

    Spokane, Washington 99202
    United States

    Site Not Available

  • Northwest Cancer Specialists

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington 98664
    United States

    Site Not Available

  • Yakima Valley Memorial Hospital

    Yakima, Washington 98902
    United States

    Site Not Available

  • Aurora Medical Gyn Group

    West Allis, Wisconsin 53227
    United States

    Site Not Available

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