A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
NCT ID: NCT00060944
Last Updated: 2014-09-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
271 participants
INTERVENTIONAL
2003-05-31
2008-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Yondelis weekly schedule
Yondelis 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
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Dexamethasone
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.
Yondelis once every 3 weeks schedule
Yondelis 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.
Yondelis
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
Dexamethasone
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
Interventions
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Yondelis
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle.
Yondelis
0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle.
Dexamethasone
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.
Dexamethasone
Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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PharmaMar
INDUSTRY
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Responsible Party
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Principal Investigators
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Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Role: STUDY_DIRECTOR
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Locations
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Los Angeles, California, United States
Aurora, Colorado, United States
Coeur d'Alene, Idaho, United States
Park Ridge, Illinois, United States
Indianapolis, Indiana, United States
Louisville, Kentucky, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Newark, New Jersey, United States
New York, New York, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Milwaukee, Wisconsin, United States
East Melbourne, , Australia
Newcastle, , Australia
Perth, , Australia
Woodville, , Australia
Leuven, , Belgium
Calgary, Alberta, Canada
London, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Edmonton, , Canada
Lyon, , France
Villejuif, , France
Düsseldorf, , Germany
Moscow, , Russia
Obninsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Barcelona, , Spain
Valencia, , Spain
Countries
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Related Links
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Demetri GD et al. J Clin Oncol. 2009;27(25):4188-96.
Other Identifiers
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ET743-STS-201
Identifier Type: OTHER
Identifier Source: secondary_id
CR004336
Identifier Type: -
Identifier Source: org_study_id
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