A Study Comparing the Combination of Trabectedin (YONDELIS) and DOXIL/CAELYX With DOXIL/CAELYX for the Treatment of Advanced-Relapsed Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

581

Participants

Timeline

Start Date

October 16, 2013

Primary Completion Date

January 18, 2018

Study Completion Date

November 16, 2018

Conditions
Ovarian NeoplasmsPeritoneal NeoplasmsFallopian Tube Neoplasms
Interventions
DRUG

Trabectedin

1.1 mg/m\^2 administered intravenously over approximately 3 hours on Day 1 of each 21-day treatment cycle.

DRUG

DOXIL

30 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 21-day treatment cycle.

DRUG

Dexamethasone

20 mg administered intravenously on Day 1 of each 21-day treatment cycle approximately 30 minutes prior to study drug infusion.

DRUG

DOXIL

50 mg/m\^2 administered intravenously over approximately 90 minutes on Day 1 of each 28-day treatment cycle.

Trial Locations (138)

Unknown

Birmingham

Phoenix

Scottsdale

Sedona

Tucson

Hot Springs

Greenbrae

La Jolla

Los Angeles

Orange

Sacramento

Englewood

New Britain

New Haven

Stamford

Fort Myers

Jacksonville

Miami

Sarasota

St. Petersburg

Tampa

Atlanta

Savannah

Chicago

Park Ridge

Indianapolis

Louisville

Covington

New Orleans

Scarborough

Worcester

Detroit

Lansing

Duluth

Edina

Columbia

Kansas City

Hackensack

Morristown

New Brunswick

Summit

Brightwaters

Hawthorne

New York

Pinehurst

Akron

Cincinnati

Cleveland

Columbus

Tulsa

Portland

Abington

Pittsburgh

Providence

Charleston

Greenville

Nashville

Austin

Bedford

Dallas

Fort Worth

Houston

San Antonio

The Woodlands

Webster

Salt Lake City

Annandale

Newport News

Roanoke

Spokane

Vancouver

Green Bay

Madison

Milwaukee

Wauwatosa

Adelaide

Ballarat

Brisbane

Gosford

Parkville

Subiaco

Toorak Gardens

Townsville

Wodonga

Woodville

Guangzhou

Jinan

Shanghai

Shenyang

Beersheba

Haifa

Holon

Jerusalem

Kfar Saba

Petah Tikva

Ramat Gan

Rehovot

Tel Aviv

Ẕerifin

Auckland

Wellington

Bydgoszcz

Gdansk

Lublin

Poznan

Warsaw

Arkhangelsk

Chelyabinsk

Ivanovo

Kirov

Krasnodar

Moscow

Nal'chik

Nizhny Novgorod

Omsk

Orenburg

Pyatigorsk

Ryazan

Saint Petersburg

Sochi

Ufa

Yaroslavl

Cape Town

Durban

eManzimtoti

Johannesburg

Port Elizabeth

Pretoria

Bern

Zurich

Bebington

Glasgow

Guildford

London

Maidstone

Manchester

Plymouth

Swansea

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PharmaMar

INDUSTRY

lead

Janssen Research & Development, LLC

INDUSTRY