A Study to Assess Treatment With 2 Different Dosing Schedules of Trabectidin Administered to Patients With Advanced Cancer
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ClinicalTrials.gov Identifier: NCT00060944 |
Recruitment Status :
Completed
First Posted : May 19, 2003
Results First Posted : September 8, 2014
Last Update Posted : September 8, 2014
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Condition or disease | Intervention/treatment | Phase |
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Liposarcoma Leiomyosarcoma | Drug: Yondelis Drug: Dexamethasone | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 271 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | 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 |
Study Start Date : | May 2003 |
Actual Primary Completion Date : | May 2008 |
Actual Study Completion Date : | May 2008 |

Arm | Intervention/treatment |
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Experimental: 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.
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Drug: 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. Drug: 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. |
Experimental: 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.
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Drug: Yondelis
1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Drug: 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. |
- Time to Progression- Independent Review [ Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years ]Time to Progression was defined as time between randomization and the first documentation of disease progression or death due to progressive disease.
- Percentage of Participants Objective Response - Independent Review [ Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years ]Percentage of participants with objective response based on assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the longest dimensions (LD) of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response.
- Duration of Response - Independent Review [ Time Frame: 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 based on assessment of confirmed CR or confirmed PR according to RECIST. Confirmed CR defined as disappearance of all target lesions. Confirmed PR defined as greater than or equal to 30 percent decrease in sum of the LD of the target lesions taking as a reference the baseline sum LD according to RECIST. Confirmed responses are those that persist on repeat imaging study greater than or equal to 4 weeks after initial documentation of response. Kaplan-Meier estimation of response duration was used to account censored participants with ongoing response.
- Progression-Free Survival - Independent Review [ Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years ]The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.
- Overall Survival [ Time Frame: From randomization to the first documentation of disease progression or death due to progressive disease, whichever occurs first, assessed up to 5 years ]The below table shows Kaplan-Meier estimate of the median time from randomization to death from any cause or first observed disease progression.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00060944
United States, California | |
Los Angeles, California, United States | |
United States, Colorado | |
Aurora, Colorado, United States | |
United States, Idaho | |
Coeur D Alene, Idaho, United States | |
United States, Illinois | |
Park Ridge, Illinois, United States | |
United States, Indiana | |
Indianapolis, Indiana, United States | |
United States, Kentucky | |
Louisville, Kentucky, United States | |
United States, Massachusetts | |
Boston, Massachusetts, United States | |
United States, Michigan | |
Ann Arbor, Michigan, United States | |
United States, Minnesota | |
Minneapolis, Minnesota, United States | |
Rochester, Minnesota, United States | |
United States, New Jersey | |
Newark, New Jersey, United States | |
United States, New York | |
New York, New York, United States | |
United States, Ohio | |
Cleveland, Ohio, United States | |
United States, Oregon | |
Portland, Oregon, United States | |
United States, Pennsylvania | |
Philadelphia, Pennsylvania, United States | |
United States, Tennessee | |
Nashville, Tennessee, United States | |
United States, Texas | |
Houston, Texas, United States | |
United States, Utah | |
Salt Lake City, Utah, United States | |
United States, Washington | |
Seattle, Washington, United States | |
United States, Wisconsin | |
Milwaukee, Wisconsin, United States | |
Australia | |
East Melbourne, Australia | |
Newcastle, Australia | |
Perth, Australia | |
Woodville, Australia | |
Belgium | |
Leuven, Belgium | |
Canada, Alberta | |
Calgary, Alberta, Canada | |
Canada, Ontario | |
London, Ontario, Canada | |
Ottawa, Ontario, Canada | |
Toronto, Ontario, Canada | |
Canada | |
Edmonton, Canada | |
France | |
Lyon, France | |
Villejuif, France | |
Germany | |
Düsseldorf, Germany | |
Russian Federation | |
Moscow N/A, Russian Federation | |
Moscow, Russian Federation | |
Obninsk N/A, Russian Federation | |
Samara N/A, Russian Federation | |
St Petersburg N/A, Russian Federation | |
St Petersburg, Russian Federation | |
Spain | |
Barcelona, Spain | |
Valencia N/A, Spain |
Study Director: | Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
Responsible Party: | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. |
ClinicalTrials.gov Identifier: | NCT00060944 |
Other Study ID Numbers: |
CR004336 ET743-STS-201 ( Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C. ) |
First Posted: | May 19, 2003 Key Record Dates |
Results First Posted: | September 8, 2014 |
Last Update Posted: | September 8, 2014 |
Last Verified: | August 2014 |
Trabectedin Yondelis ET-743 Ecteinascidin Anthracycline Ifosfamide |
Dexamethasone Intravenous Cancer Malignant Metastatic |
Leiomyosarcoma Liposarcoma Neoplasms, Muscle Tissue Neoplasms, Connective and Soft Tissue Neoplasms by Histologic Type Neoplasms Sarcoma Neoplasms, Adipose Tissue Dexamethasone Dexamethasone acetate Trabectedin BB 1101 Anti-Inflammatory Agents Antiemetics |
Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Antineoplastic Agents, Hormonal Antineoplastic Agents Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents, Alkylating Alkylating Agents |