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

NCT ID: NCT00262990

Last Updated: 2020-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

829 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-11-30

Brief Summary

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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 Description

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Conditions

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Ovarian Cancer Fallopian Tube Cancer Peritoneal Neoplasms

Keywords

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Epithelial ovarian cancer fallopian tube cancer peritoneal cancer primary cancer recurrent cancer doxorubicin taxane chemotherapy platinum chemotherapy Patupilone taxane platinum resistant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patupilone

Group Type EXPERIMENTAL

EPO906 (Patupilone)

Intervention Type DRUG

doxorubicin

Group Type ACTIVE_COMPARATOR

doxorubicin

Intervention Type DRUG

Interventions

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EPO906 (Patupilone)

Intervention Type DRUG

doxorubicin

Intervention Type DRUG

Other Intervention Names

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Patupilone

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Alaska Cancer Research & Education Center

Anchorage, Alaska, United States

Site Status

Northern Arizona Hematology & Oncology Associates

Flagstaff, Arizona, United States

Site Status

Mayo Center for Women's Health

Scottsdale, Arizona, United States

Site Status

Northern Arizona Hematology & Oncology Associates

Sedona, Arizona, United States

Site Status

Genesis Cancer Center

Hot Springs, Arkansas, United States

Site Status

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Site Status

Yanagihara, Ronald H.

Gilroy, California, United States

Site Status

California Cancer Care, Inc.

Greenbrae, California, United States

Site Status

University of California - San Diego/ Moores Cancer Center

La Jolla, California, United States

Site Status

LAC & USC Women's & Children's Hospital

Los Angeles, California, United States

Site Status

Gynecologic Oncology associates

Newport Beach, California, United States

Site Status

UC Davis Cancer Center

Sacramento, California, United States

Site Status

California Pacific Medical Center Research Institute

San Francisco, California, United States

Site Status

Anschutz Cancer Pavilion

Aurora, Colorado, United States

Site Status

Anschutz Cancer Pavilion - Clinical Investigations Core

Aurora, Colorado, United States

Site Status

University Of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Yale University School of Medicine

New Haven, Connecticut, United States

Site Status

Christiana Gynecologic Oncology, LLC

Newark, Delaware, United States

Site Status

Washington Hospital Center/Medstar Research Institute

Washington D.C., District of Columbia, United States

Site Status

Florida Gynecologic Oncology

Fort Myers, Florida, United States

Site Status

Miami Cancer Center at Mercy Hospital

Miami, Florida, United States

Site Status

Miami Cancer Center at University Hospital

Miami, Florida, United States

Site Status

University of Miami

Miami, Florida, United States

Site Status

Mt. Sinai Medical Center

Miami, Florida, United States

Site Status

Advanced Medical Specialties

Miami, Florida, United States

Site Status

Ocala Oncology Center

Ocala, Florida, United States

Site Status

MD Anderson Cancer Center of Orlando

Orlando, Florida, United States

Site Status

Oncology & Hematology Associates of West Broward

Tamarac, Florida, United States

Site Status

Xelero Medical Research/Giselle Ghurani

Tampa, Florida, United States

Site Status

Medical College of Georgia

Augusta, Georgia, United States

Site Status

Memorial Health University Medical Center

Savannah, Georgia, United States

Site Status

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

Honolulu, Hawaii, United States

Site Status

Northwest Memorial Hospital

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Cancer Institute of Central Illinois/Decatur Memorial Hospital

Decatur, Illinois, United States

Site Status

Indiana University Obstetrics

Indianapolis, Indiana, United States

Site Status

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

Indianapolis, Indiana, United States

Site Status

Gynecologic Oncology of Indiana/St. Francis Cancer Research Foundation

Indianapolis, Indiana, United States

Site Status

Northern Indiana Cancer Research Consortium

South Bend, Indiana, United States

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Louisville Oncology

Louisville, Kentucky, United States

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Franklin Square Hospital Center

Baltimore, Maryland, United States

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Boston University Medical Center Hospital

Boston, Massachusetts, United States

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Providence Cancer Center

Southfield, Michigan, United States

Site Status

Minnesota Oncology/Hematology, PA

Burnsville, Minnesota, United States

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St. Luke's Hospital

Duluth, Minnesota, United States

Site Status

Minnesota Oncology/Hematology, PA

Edina, Minnesota, United States

Site Status

Minnesota Oncology/Hematology Associates of Central Illinois

Minneapolis, Minnesota, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

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Metro-MN CCOP

Saint Louis Park, Minnesota, United States

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Minnesota Oncology Hematology

Saint Paul, Minnesota, United States

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The West Clinic

Corinth, Mississippi, United States

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The West Clinic

Southaven, Mississippi, United States

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

Kansas City, Missouri, United States

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Washington University School of Medicine

St Louis, Missouri, United States

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Southeast Nebraska Oncology/Southeast Nebraska Cancer Center

Lincoln, Nebraska, United States

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Comprehensive Cancer Centers of Nevada

Las Vegas, Nevada, United States

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Women's Cancer Center of Nevada

Las Vegas, Nevada, United States

Site Status

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Hematology and Oncology Associates of Northern New Jersey

Morristown, New Jersey, United States

Site Status

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

New Brunswick, New Jersey, United States

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New York Oncology Hematology, P.C.

Albany, New York, United States

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Schwartz Gynecologic Oncology, PLLC

Babylon, New York, United States

Site Status

Bellview Hospital

New York, New York, United States

Site Status

New York University School of Medicine/NYU Cancer Institute

New York, New York, United States

Site Status

NYU Cancer Institute

New York, New York, United States

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St. Vincent Catholic Medical Center of New York

Staten Island, New York, United States

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Brody School of Medicine

Greenville, North Carolina, United States

Site Status

New Hanover Regional Medical Center/Zimmer Cancer Center

Wilmington, North Carolina, United States

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Ohio State University Medical Center

Columbus, Ohio, United States

Site Status

Camelot Women's Cancer

Columbus, Ohio, United States

Site Status

The Arthur G. James Cancer Hospital

Columbus, Ohio, United States

Site Status

Cancer Care Associates

Tulsa, Oklahoma, United States

Site Status

Oncology Associates of Oregon, PC/Willaimette Valley Cancer Center

Eugene, Oregon, United States

Site Status

Northwest Cancer Specialists, P.C.

Portland, Oregon, United States

Site Status

Willamette Valley Cancer Center

Springfield, Oregon, United States

Site Status

Medical Oncology Associates of Wyoming Valley, PC

Kingston, Pennsylvania, United States

Site Status

Magee - Women's Hospital

Pittsburgh, Pennsylvania, United States

Site Status

GYN Oncology Research/Gynecologic Oncology Research & Development, LLC

Greenville, South Carolina, United States

Site Status

Chattanooga GYN Oncology

Chattanooga, Tennessee, United States

Site Status

Hall and Martin MDs, PC

Knoxville, Tennessee, United States

Site Status

The West Clinic

Memphis, Tennessee, United States

Site Status

West Clinic

Memphis, Tennessee, United States

Site Status

Texas Oncology, P.A.

Austin, Texas, United States

Site Status

Texas Oncology

Austin, Texas, United States

Site Status

Texas Oncology, P.A.

Bedford, Texas, United States

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Texas Oncology, P.A.

Dallas, Texas, United States

Site Status

Sammons Cancer Center

Dallas, Texas, United States

Site Status

Texas Oncology, P.A.

Dallas, Texas, United States

Site Status

Texas Oncology, P.A.

Fort Worth, Texas, United States

Site Status

Oncology Consultants P.A.

Houston, Texas, United States

Site Status

Cancer Care Center of South Texas

San Antonio, Texas, United States

Site Status

Waco Cancer Care & Research Center

Waco, Texas, United States

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Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

Fletcher Allen Health Care

Burlington, Vermont, United States

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Cancer Outreach Associates

Abingdon, Virginia, United States

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Northern Virginia Pelvic Surgery Associates

Annandale, Virginia, United States

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Virginia Oncology Associates

Newport News, Virginia, United States

Site Status

Virginia Oncology Associates

Norfolk, Virginia, United States

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Virginia Commonwealth University/VCU Massey Cancer Center

Richmond, Virginia, United States

Site Status

Gersh, Robert

Spokane, Washington, United States

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Northwest Cancer Specialists, P.C.

Vancouver, Washington, United States

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Northwest Cancer Specialists

Vancouver, Washington, United States

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Yakima Valley Memorial Hospital

Yakima, Washington, United States

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Aurora Medical Gyn Group

West Allis, Wisconsin, United States

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Novartis Investigative Site

Adelaide, , Australia

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Novartis Investigative Site

Herston, , Australia

Site Status

Novartis Investigative Site

Nedlands, WA, , Australia

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Novartis Investigative Site

South Brisbane, , Australia

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Novartis Investigative Site

St Leonards, , Australia

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Novartis Investigative Site

Wodonga, , Australia

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BC Cancer Agency

Vancouver, British Columbia, Canada

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Novartis Investigative Site

Calgary, , Canada

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Novartis Investigative Site

Montreal, , Canada

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Novartis Investigative Site

North York, , Canada

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Novartis Investigative Site

Québec, , Canada

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Novartis Investigative Site

Sherbrooke, , Canada

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Novartis Investigative Site

Toronto, , Canada

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Novartis Investigative Site

Odense, , Denmark

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Novartis Investigative Site

Vejle, , Denmark

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Novartis Investigative Site

Helsinki, , Finland

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Novartis Investigative Site

Kuopio, , Finland

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Novartis Investigative Site

Tampere, , Finland

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Novartis Investigative Site

Amboise, , France

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Novartis Investigative Site

Bordeaux, , France

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Novartis Investigative Site

Caen, , France

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Novartis Investigative Site

Herblain Cedec, , France

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Novartis Investigative Site

Villejuif, , France

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Novartis Investigative Site

Athens, , Greece

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Novartis Investigative Site

Bologna, , Italy

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Novartis Investigative Site

Milan, , Italy

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Novartis Investigative Site

Modena, , Italy

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Novartis Investigative Site

Monza, , Italy

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Novartis Investigative Site

Padua, , Italy

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Novartis Investigative Site

Roma, , Italy

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Novartis Investigative Site

Torino, , Italy

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Novartis Investigative Site

Krakow, , Poland

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Novartis Investigative Site

Cape Town, , South Africa

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Novartis Investigative Site

Johannesburg, Gauteng, , South Africa

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Novartis Investigative Site

Klerksdorp, , South Africa

Site Status

Novartis Investigative Site

Port Elizabeth, , South Africa

Site Status

Novartis Investigative Site

Pretoria, Gauteng, , South Africa

Site Status

Novartis Investigative Site

Pretoria, Guateng, , South Africa

Site Status

Novartis Investigative Site

Sandton, Gauteng, , South Africa

Site Status

Novartis Investigative Site

Barcelona, , Spain

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Novartis Investigative Site

Madrid, , Spain

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Novartis Investigative Site

Glasgow, , United Kingdom

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Novartis Investigative Site

London, , United Kingdom

Site Status

Novartis Investigative Site

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Novartis Investigative Site

Wolverhampton, , United Kingdom

Site Status

Countries

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United States Australia Canada Denmark Finland France Greece Italy Poland South Africa Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 37407274 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22987083 (View on PubMed)

Related Links

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http://www.clinicaltrials.gov

In the search box enter NCT00262990

https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=3944

Results for CEPO906A2303 from the Novartis Clinical Trials website

Other Identifiers

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CEPO906A2303

Identifier Type: -

Identifier Source: org_study_id