A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
A Randomized, Multicenter, Open-label Study of Yondelis (ET-743 Ecteinascidin) Administered by 2 Different Schedules (Weekly for 3 of 4 Weeks vs. q3 Weeks) in Subjects With Locally Advanced or Metastatic Liposarcoma or Leiomyosarcoma Following Treatment With an Anthracycline and Ifosfamide
2 other identifiers
interventional
271
8 countries
39
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2003
Longer than P75 for phase_2
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2003
CompletedFirst Submitted
Initial submission to the registry
May 16, 2003
CompletedFirst Posted
Study publicly available on registry
May 19, 2003
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedResults Posted
Study results publicly available
September 8, 2014
CompletedSeptember 8, 2014
August 1, 2014
5 years
May 16, 2003
January 14, 2014
August 28, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Progression- Independent Review
Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Secondary Outcomes (4)
Percentage of Participants Objective Response - Independent Review
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Duration of Response - Independent Review
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Progression-Free Survival - Independent Review
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Overall Survival
From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years
Study Arms (2)
Yondelis weekly schedule
EXPERIMENTALYondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion.
Yondelis once every 3 weeks schedule
EXPERIMENTALYondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.
Interventions
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (39)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Aurora, Colorado, United States
Unknown Facility
Coeur d'Alene, Idaho, United States
Unknown Facility
Park Ridge, Illinois, United States
Unknown Facility
Indianapolis, Indiana, United States
Unknown Facility
Louisville, Kentucky, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Ann Arbor, Michigan, United States
Unknown Facility
Minneapolis, Minnesota, United States
Unknown Facility
Rochester, Minnesota, United States
Unknown Facility
Newark, New Jersey, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Cleveland, Ohio, United States
Unknown Facility
Portland, Oregon, United States
Unknown Facility
Philadelphia, Pennsylvania, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Houston, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Seattle, Washington, United States
Unknown Facility
Milwaukee, Wisconsin, United States
Unknown Facility
East Melbourne, Australia
Unknown Facility
Newcastle, Australia
Unknown Facility
Perth, Australia
Unknown Facility
Woodville, Australia
Unknown Facility
Leuven, Belgium
Unknown Facility
Calgary, Alberta, Canada
Unknown Facility
London, Ontario, Canada
Unknown Facility
Ottawa, Ontario, Canada
Unknown Facility
Toronto, Ontario, Canada
Unknown Facility
Edmonton, Canada
Unknown Facility
Lyon, France
Unknown Facility
Villejuif, France
Unknown Facility
Düsseldorf, Germany
Unknown Facility
Moscow, Russia
Unknown Facility
Obninsk, Russia
Unknown Facility
Saint Petersburg, Russia
Unknown Facility
Samara, Russia
Unknown Facility
Barcelona, Spain
Unknown Facility
Valencia, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Director
- Organization
- Janssen R&D US
Study Officials
- STUDY DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 16, 2003
First Posted
May 19, 2003
Study Start
May 1, 2003
Primary Completion
May 1, 2008
Study Completion
May 1, 2008
Last Updated
September 8, 2014
Results First Posted
September 8, 2014
Record last verified: 2014-08