A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer

Completed · Phase 2

Conditions studied: Liposarcoma, Leiomyosarcoma

In brief

The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Key facts

Study ID

NCT00060944

Run by

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

People needed

271

Starts

2003-05-01

Expected to finish

2008-05-01

Last updated by the study team

2014-09-08

Who can join

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

You may qualify if…

• Have advanced liposarcoma or leiomyosarcoma that has metastasized (spread)
• Have a pathology specimen available for centralized review
• Have progressive or relapsed (reappearance of) disease, received treatment with anthracycline and/or ifosfamide before enrollment in study, and have at least one measurable tumor lesion
• Have adequate bone marrow, liver and kidney function
• Have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

You may not qualify if…

• Previous exposure to Yondelis i.v. formulation, ET-743 (ecteinascidin)
• Cancer that has metastasized (spread) to the central nervous system
• Active viral hepatitis or chronic liver disease
• Unstable cardiac (heart) condition including congestive heart failure or angina pectoris (heart pain), myocardial infarction (heart attack) within 1 year before enrollment
• History of another neoplastic (malignant or nonmalignant tumor) disease (except basal cell carcinoma or cervical carcinoma adequately treated), unless in remission for 5 years or more before enrollment

Where it is running

• Study site — Los Angeles, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Coeur d'Alene, Idaho, United States
• Study site — Park Ridge, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Louisville, Kentucky, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Study site — Minneapolis, Minnesota, United States
• Study site — Rochester, Minnesota, United States
• Study site — Newark, New Jersey, United States
• Study site — New York, New York, United States
• Study site — Cleveland, Ohio, United States
• Study site — Portland, Oregon, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Salt Lake City, Utah, United States
• Study site — Seattle, Washington, United States
• Study site — Milwaukee, Wisconsin, United States
• Study site — East Melbourne, Australia
• Study site — Newcastle, Australia
• Study site — Perth, Australia
• Study site — Woodville, Australia
• Study site — Leuven, Belgium

Full record on ClinicalTrials.gov

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