An Efficacy and Safety Study for Yondelis (Trabectedin) in Patients With Advanced Relapsed Ovarian Cancer

Completed · Phase 3

Conditions studied: Ovarian Cancer

In brief

The purpose of the study is to compare the progression-free survival (PFS) of the combination of trabectedin + DOXIL with DOXIL monotherapy in patients with ovarian cancer.

Key facts

Study ID

NCT00113607

Run by

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

People needed

672

Starts

2005-04-01

Expected to finish

2010-11-01

Last updated by the study team

2014-06-27

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Histologically proven epithelial ovarian cancer, epithelial fallopian tube cancer, or primary peritoneal cancer
• Prior treatment with only 1 platinum based chemotherapy regimen
• Eastern Cooperative Oncology Group status of not more than 2
• Progression more than 6 months after the start of initial chemotherapy treatment

You may not qualify if…

• Treatment with more than 1 prior chemotherapy regimen
• Progression within 6 months after starting initial chemotherapy
• Prior exposure to anthracyclines
• Unwilling or unable to have central venous catheter
• Known clinically relevant central nervous system metastasis

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Los Angeles, California, United States
• Study site — Newport Beach, California, United States
• Study site — Orange, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Stamford, Connecticut, United States
• Study site — Tampa, Florida, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Boston, Massachusetts, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — St Louis, Missouri, United States
• Study site — Morristown, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Charlotte, North Carolina, United States
• Study site — Greenville, North Carolina, United States
• Study site — Winston-Salem, North Carolina, United States
• Study site — Cleveland, Ohio, United States
• Study site — Toledo, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Pittsburgh, Pennsylvania, United States
• Study site — Greenville, South Carolina, United States
• Study site — Chattanooga, Tennessee, United States
• Study site — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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