A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Pati⦠(NCT00060944) | Clinical Trial Compass
CompletedPhase 2
A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
United States271 participantsStarted 2003-05
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
What they're measuring
1
Time to Progression- Independent Review
Timeframe: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Trial details
NCT IDNCT00060944
SponsorJohnson & Johnson Pharmaceutical Research & Development, L.L.C.