A Study Comparing the Combination of Doxil and Yondelis, to Doxil Alone for Subjects With Ovarian Cancer

Condition(s) targeted: Ovarian Cancer

Intervention: Yondelis (Drug); DOXIL (Drug); DOXIL (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Official(s) and/or principal investigator(s):
Johnson & Johnson Pharmaceutical Research & Development, LLC

The purpose of this research study is to determine if the combination of Yondelis and Doxil is better at improving overall survival over Doxil alone in subjects with relapsed advanced ovarian cancer.

Official title: An Open-Label Multicenter Randomized Phase 3 Study Comparing the Combination of Doxil/Caelyx and Yondelis to Doxil/Caelyx Alone in Subjects With Advanced Relapsed Ovarian Cancer

Study design: Treatment, Randomized, Open Label, Parallel Assignment

Primary outcome: The primary objective of the study is to demonstrate that the combination of YONDELIS™ (trabectedin) for intravenous infusion + DOXIL®/CAELYX® improves overall survival over DOXIL alone in the management of ovarian cancer in second line therapy.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

- Female, age 18 or older

- Histologically proven epithelial ovarian cancer

- Prior treatment with only 1 platinum-based chemotherapy regimen

- Eastern Cooperative Oncology Group (ECOG) performance status ≤2

- Recurrence or progression more than six months after the beginning of the initial line

of platinum-based chemotherapy for ovarian cancer

Exclusion Criteria:

- Subjects treated with more than 1 prior chemotherapy regimen (including adjuvant

therapy)

- Refractory disease

- Isolated rise in CA-125 without documented radiological evidence of disease

progression

Rosario, Argentina

Santa Fe, Argentina

Buenos Aires, Argentina

Buenos Aires, Argentina

Buenos Aires, Argentina

Buenos Aires C1405CUB, Argentina

St Leonards, Australia

Toorak Gardens, Australia

Adelaide, Australia

East Bentleigh, Australia

Douglas, Australia

Wilrijk, Belgium

Hasselt, Belgium

Gent, Belgium

Leuven, Belgium

Edegem, Belgium

Cerqueira Cesar, Brazil

Sao Paulo, Brazil

Belo Horizonte, Brazil

Londrina, Brazil

Santo Andre, Brazil

Quebec, Canada

Vina del Mar, Chile

Santiago, Chile

Santiago, Chile

Cedex 63011, France

Chartres 28630, France

Paris Cedex 75181, France

Pierre Benite 69495, France

Heidelberg, Germany

Jena, Germany

Mainz, Germany

Wilhelmshaven, Germany

Karlsruhe, Germany

Villingen-Schwenningen, Germany

Giessen, Germany

Dusseldorf 40479, Germany

Pokfulam, Hong Kong

Shatin, Hong Kong

Chai Wan, Hong Kong

Milano 20142, Italy

Milano 20141, Italy

Roma 00166, Italy

Campobasso 86100, Italy

Seoul, Korea, Republic of

Seoul, Korea, Republic of

Seoul, Korea, Republic of

SEOUL, Korea, Republic of

Seoul, Korea, Republic of

Groningen, Netherlands

Maastricht, Netherlands

Amsterdam, Netherlands

Enschede, Netherlands

Warszawa, Poland

Gdansk, Poland

Wroclaw, Poland

Poznan, Poland

Krakow, Poland

Poznan, Poland

Gliwice, Poland

Olsztyn, Poland

Moscow, Russian Federation

Moscow, Russian Federation

Orenburg, Russian Federation

Obninsk, Russian Federation

St Petersburg, Russian Federation

Moscow, Russian Federation

St Petersburg, Russian Federation

Moscow, Russian Federation

Samara 443066, Russian Federation

Chelyabinsk 454087, Russian Federation

Moscow 119121, Russian Federation

Cheliabinsk 454087, Russian Federation

Moscow 119121, Russian Federation

Saint Petersburg 197758, Russian Federation

Moscow 129301, Russian Federation

Singapore, Singapore

Madrid, Spain

Zaragoza, Spain

Madrid, Spain

Badalona, Spain

Guadalajara, Spain

valencia, Spain

Gothenburg, Sweden

Umea, Sweden

Uppsala, Sweden

Kaohsiung, Taiwan

Taipei, Taiwan

Kaohsiung, Taiwan

Taoyuan, Taiwan

Taipei, Taiwan

Taipei, Taiwan

Kaohsiung 3F, Taiwan

National Taiwan University Hospital, Taipei 100, Taiwan

Nottingham, United Kingdom

London, United Kingdom

Sutton, United Kingdom

Poole, United Kingdom

Sheffield, United Kingdom

Birmingham, United Kingdom

Edinburgh, United Kingdom

Leicester, United Kingdom

Mobile, Alabama 36608, United States

Calgary, Alberta, Canada

Edmonton, Alberta T6G1z2, Canada

Tuscon, Arizona, United States

Newport Beach, California 92663, United States

Orange, California 92868, United States

Orange, California, United States

Sacramento, California 95817, United States

Englewood, Colorado 80110, United States

Englewood, Colorado, United States

Stamford, Connecticut 06902-3628, United States

Stamford, Connecticut, United States

New Haven, Connecticut 06520, United States

Tampa, Florida, United States

Coeur D' Alene, Idaho 83814, United States

Louisville, Kentucky, United States

New Orleans, Louisiana 70115, United States

Metaerie, Louisiana, United States

Boston, Massachusetts, United States

Boston, Massachusetts, United States

Minneota, Minnesota 55455, United States

University of Minnesota, Minneapolis, Minnesota 55455, United States

Kansas City, Missouri 64111, United States

St. Louis, Missouri 63131, United States

Kansas City, Missouri, United States

St Louis, Missouri, United States

Morristown, New Jersey 07962, United States

New York, New York, United States

New York, New York, United States

Greenville, North Carolina 27834, United States

Winston-Salem, North Carolina 27103, United States

Charlotte, North Carolina, United States

Greenville, North Carolina, United States

Winston-Salem, North Carolina, United States

Winston-Salem, North Carolina, United States

Toledo, Ohio 43614, United States

Cleveland, Ohio, United States

Ottawa, Ontario, Canada

Portland, Oregon, United States

Pittsburgh, Pennsylvania 15213, United States

Pittsburg, Pennsylvania, United States

Montreal, Quebec, Canada

Charleston, South Carolina 29425, United States

Greenville, South Carolina, United States

Chattanooga, Tennessee 37403, United States

Chattanooga, Tennessee, United States

Nashville, Tennessee, United States

Galveston, Texas, United States

Dallas, Texas, United States

Dallas, Texas 75390, United States

website containing information for how to contact a participating site for this ovarian cancer study

Starting date: April 2005
Ending date: November 2009
Last updated: December 27, 2007