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Ovarian CancerPhase 3NCT00262990

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

A Phase 3 study testing EPO906 (Patupilone) and doxorubicin in people with Ovarian Cancer and Fallopian Tube Cancer, run by Novartis Pharmaceuticals at 149 sites in 12 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
EPO906 (Patupilone) and doxorubicin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
829 participants
Where
149 sitesin 12 countries
Study dates
Nov 2005to Feb 2010
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

149 sites in 12 countries.

149 sites in 12 countries

United States104 sites

  • Cancer Outreach Associates

    Abingdon, Virginia, 24211

  • New York Oncology Hematology, P.C.

    Albany, New York, 12208

  • Alaska Cancer Research & Education Center

    Anchorage, Alaska, 99508

  • Northern Virginia Pelvic Surgery Associates

    Annandale, Virginia, 22003

  • Medical College of Georgia

    Augusta, Georgia, 30912

  • Anschutz Cancer Pavilion

    Aurora, Colorado, 80045

  • Anschutz Cancer Pavilion - Clinical Investigations Core

    Aurora, Colorado, 90045

  • Texas Oncology, P.A.

    Austin, Texas, 78731

  • Texas Oncology

    Austin, Texas, 78745

  • Schwartz Gynecologic Oncology, PLLC

    Babylon, New York, 11702

  • Franklin Square Hospital Center

    Baltimore, Maryland, 21237

  • Texas Oncology, P.A.

    Bedford, Texas, 76022

  • Boston University Medical Center Hospital

    Boston, Massachusetts, 02118

  • Fletcher Allen Health Care

    Burlington, Vermont, 05401

  • Minnesota Oncology/Hematology, PA

    Burnsville, Minnesota, 55337

  • Chattanooga GYN Oncology

    Chattanooga, Tennessee, 37403

  • Northwest Memorial Hospital

    Chicago, Illinois, 60611

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • Ohio State University Medical Center

    Columbus, Ohio, 43210-1228

  • Camelot Women's Cancer

    Columbus, Ohio, 43214

  • The Arthur G. James Cancer Hospital

    Columbus, Ohio, 43214

  • The West Clinic

    Corinth, Mississippi, 38834

  • Texas Oncology, P.A.

    Dallas, Texas, 75231

  • Sammons Cancer Center

    Dallas, Texas, 75246

  • Texas Oncology, P.A.

    Dallas, Texas, 75246

  • Cancer Institute of Central Illinois/Decatur Memorial Hospital

    Decatur, Illinois, 62526

  • University Of Colorado Health Sciences Center

    Denver, Colorado, 80262

  • St. Luke's Hospital

    Duluth, Minnesota, 55805

  • Minnesota Oncology/Hematology, PA

    Edina, Minnesota, 55435

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

    Eugene, Oregon, 97401-8122

  • Northern Arizona Hematology & Oncology Associates

    Flagstaff, Arizona, 86001

  • Florida Gynecologic Oncology

    Fort Myers, Florida, 33901

  • Texas Oncology, P.A.

    Fort Worth, Texas, 76104

  • Yanagihara, Ronald H.

    Gilroy, California, 95020

  • California Cancer Care, Inc.

    Greenbrae, California, 94904

  • Brody School of Medicine

    Greenville, North Carolina, 27834

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

    Greenville, South Carolina, 29601

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

    Honolulu, Hawaii, 96826

  • Genesis Cancer Center

    Hot Springs, Arkansas, 71913

  • Oncology Consultants P.A.

    Houston, Texas, 77024

  • Indiana University Obstetrics

    Indianapolis, Indiana, 00144

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

    Indianapolis, Indiana, 46202

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

    Indianapolis, Indiana, 46267

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

    Kansas City, Missouri, 64111

  • Medical Oncology Associates of Wyoming Valley, PC

    Kingston, Pennsylvania, 18704

  • Hall and Martin MDs, PC

    Knoxville, Tennessee, 37920

  • University of California - San Diego/ Moores Cancer Center

    La Jolla, California, 92093-0987

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89109

  • Women's Cancer Center of Nevada

    Las Vegas, Nevada, 89109

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Southeast Nebraska Oncology/Southeast Nebraska Cancer Center

    Lincoln, Nebraska, 68510

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

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

    Los Angeles, California, 90033

  • Louisville Oncology

    Louisville, Kentucky, 40202

  • The West Clinic

    Memphis, Tennessee, 38104

  • West Clinic

    Memphis, Tennessee, 38120

  • Miami Cancer Center at Mercy Hospital

    Miami, Florida, 33133

  • Miami Cancer Center at University Hospital

    Miami, Florida, 33133

  • University of Miami

    Miami, Florida, 33136

  • Mt. Sinai Medical Center

    Miami, Florida, 33143

  • Advanced Medical Specialties

    Miami, Florida, 33176

  • Minnesota Oncology/Hematology Associates of Central Illinois

    Minneapolis, Minnesota, 55404

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Hematology and Oncology Associates of Northern New Jersey

    Morristown, New Jersey, 07962

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

    New Brunswick, New Jersey, 07090

  • Yale University School of Medicine

    New Haven, Connecticut, 06520

  • Bellview Hospital

    New York, New York, 10016

  • New York University School of Medicine/NYU Cancer Institute

    New York, New York, 10016

  • NYU Cancer Institute

    New York, New York, 10016

  • Christiana Gynecologic Oncology, LLC

    Newark, Delaware, 19713

  • Gynecologic Oncology associates

    Newport Beach, California, 92663

  • Virginia Oncology Associates

    Newport News, Virginia, 23606

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Ocala Oncology Center

    Ocala, Florida, 34471

  • MD Anderson Cancer Center of Orlando

    Orlando, Florida, 32806

  • Magee - Women's Hospital

    Pittsburgh, Pennsylvania, 15213

  • Northwest Cancer Specialists, P.C.

    Portland, Oregon, 97227

  • Virginia Commonwealth University/VCU Massey Cancer Center

    Richmond, Virginia, 23298

  • UC Davis Cancer Center

    Sacramento, California, 95817

  • Metro-MN CCOP

    Saint Louis Park, Minnesota, 55416

  • Minnesota Oncology Hematology

    Saint Paul, Minnesota, 55102-2389

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • Cancer Care Center of South Texas

    San Antonio, Texas, 78229

  • California Pacific Medical Center Research Institute

    San Francisco, California, 94115

  • Memorial Health University Medical Center

    Savannah, Georgia, 31404

  • Mayo Center for Women's Health

    Scottsdale, Arizona, 85259

  • Northern Arizona Hematology & Oncology Associates

    Sedona, Arizona, 86336

  • Northern Indiana Cancer Research Consortium

    South Bend, Indiana, 46617

  • The West Clinic

    Southaven, Mississippi, 38671

  • Providence Cancer Center

    Southfield, Michigan, 48075

  • Gersh, Robert

    Spokane, Washington, 99202

  • Willamette Valley Cancer Center

    Springfield, Oregon, 97477

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • St. Vincent Catholic Medical Center of New York

    Staten Island, New York, 10310

  • Oncology & Hematology Associates of West Broward

    Tamarac, Florida, 33321

  • Xelero Medical Research/Giselle Ghurani

    Tampa, Florida, 33607

  • Cancer Care Associates

    Tulsa, Oklahoma, 74136

  • Northwest Cancer Specialists, P.C.

    Vancouver, Washington, 98664

  • Northwest Cancer Specialists

    Vancouver, Washington, 98664

  • Waco Cancer Care & Research Center

    Waco, Texas, 76712

  • Washington Hospital Center/Medstar Research Institute

    Washington D.C., District of Columbia, 20010-2931

  • Aurora Medical Gyn Group

    West Allis, Wisconsin, 53227

  • New Hanover Regional Medical Center/Zimmer Cancer Center

    Wilmington, North Carolina, 28401

  • Yakima Valley Memorial Hospital

    Yakima, Washington, 98902

Other trials in United States

Canada7 sites

  • Novartis Investigative Site

    Calgary

  • Novartis Investigative Site

    Montreal

  • Novartis Investigative Site

    North York

  • Novartis Investigative Site

    Québec

  • Novartis Investigative Site

    Sherbrooke

  • Novartis Investigative Site

    Toronto, M5G 2M9

  • BC Cancer Agency

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Italy7 sites

  • Novartis Investigative Site

    Bologna

  • Novartis Investigative Site

    Milan

  • Novartis Investigative Site

    Modena

  • Novartis Investigative Site

    Monza

  • Novartis Investigative Site

    Padova

  • Novartis Investigative Site

    Roma

  • Novartis Investigative Site

    Torino

Other trials in Italy

South Africa7 sites

  • Novartis Investigative Site

    Cape Town

  • Novartis Investigative Site

    Johannesburg, Gauteng

  • Novartis Investigative Site

    Klerksdorp

  • Novartis Investigative Site

    Port Elizabeth

  • Novartis Investigative Site

    Pretoria, Gauteng

  • Novartis Investigative Site

    Pretoria, Guateng

  • Novartis Investigative Site

    Sandton, Gauteng

Other trials in South Africa

Australia6 sites

  • Novartis Investigative Site

    Adelaide

  • Novartis Investigative Site

    Herston

  • Novartis Investigative Site

    Nedlands, WA

  • Novartis Investigative Site

    South Brisbane

  • Novartis Investigative Site

    St Leonards

  • Novartis Investigative Site

    Wodonga

Other trials in Australia

France5 sites

  • Novartis Investigative Site

    Amboise

  • Novartis Investigative Site

    Bordeaux

  • Novartis Investigative Site

    Caen

  • Novartis Investigative Site

    Herblain Cedec

  • Novartis Investigative Site

    Villejuif

Other trials in France

United Kingdom4 sites

  • Novartis Investigative Site

    Glasgow

  • Novartis Investigative Site

    London

  • Novartis Investigative Site

    Metropolitan Borough of Wirral

  • Novartis Investigative Site

    Wolverhampton

Other trials in United Kingdom

Finland3 sites

  • Novartis Investigative Site

    Helsinki

  • Novartis Investigative Site

    Kuopio

  • Novartis Investigative Site

    Tampere

Other trials in Finland

Denmark2 sites

  • Novartis Investigative Site

    Odense

  • Novartis Investigative Site

    Vejle

Other trials in Denmark

Spain2 sites

  • Novartis Investigative Site

    Barcelona

  • Novartis Investigative Site

    Madrid

Other trials in Spain

Greece1 site

  • Novartis Investigative Site

    Athens

Other trials in Greece

Poland1 site

  • Novartis Investigative Site

    Krakow

Other trials in Poland

About this study

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

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.

Being tested
EPO906 (Patupilone), doxorubicin
Keywords
Epithelial ovarian cancer, fallopian tube cancer, peritoneal cancer, primary cancer, recurrent cancer, doxorubicin, taxane chemotherapy, platinum chemotherapy, Patupilone, taxane platinum resistant
Medical subject headings
Ovarian Neoplasms, Fallopian Tube Neoplasms, Peritoneal Neoplasms, Carcinoma, Ovarian Epithelial, Neoplasms, Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EPO906 (Patupilone)Drug

    Also called Patupilone

  • doxorubicinDrug

Study groups in NCT00262990
Study groupRoleWhat they receive
PatupiloneExperimentalNot described
Receives: Drug: EPO906 (Patupilone)
doxorubicinActive comparatorNot described
Receives: Drug: doxorubicin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer

    Measured: every 8 weeks

Secondary outcomes (7)

  1. To determine the duration of overall response in patients with complete response (CR) or partial response (PR) or stable disease (SD)

    Measured: End of study

  2. To determine the progression-free survival (PFS) of patients treated with patupilone

    Measured: end of study

  3. To determine the time to disease progression (TTP) of patients treated with patupilone

    Measured: end of study

  4. To determine overall best tumor response (CR, PR, SD, PD and Unknown)

    Measured: end of study

  5. To investigate the safety and tolerability of patupilone

    Measured: end of study

  6. To evaluate the pharmacokinetics (PK) of patupilone from all patients

    Measured: end of study

  7. To explore relationships between Cmin (pre-dose patupilone blood concentration) and efficacy/adverse events

    Measured: end of study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Dec 2005 (estimated)
  2. Study startNov 2005
  3. Primary completionFeb 2010

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
829 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00262990
Sponsor's protocol ID
CEPO906A2303
Status last verified
May 2012
First submitted
6 Dec 2005
Last updated
17 Dec 2020
Results posted
No

Publications

  • 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.

    PubMed 37407274

  • Colombo 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.

    PubMed 22987083

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EPO906 (Patupilone) and doxorubicin in people with Ovarian Cancer and Fallopian Tube Cancer, run by Novartis Pharmaceuticals at 149 sites in 12 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 149 sites in United States, Canada, Italy, South Africa, Australia and 7 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

To show superiority of patupilone in overall survival compared to doxorubicin in taxane/platinum resistant patients with ovarian cancer (time frame: every 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00262990, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020; AzTrials last refreshed its copy on 8 Nov 2026.

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