- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00796120
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
December 9, 2015 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
The purpose of this study is to evaluate the efficacy and safety of trabectedin compared to standard doxorubicin in participants with advanced translocation-related sarcomas (cancer of connective tissue cells) (TRS).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is a randomized (study drug assigned by chance), multicenter (when more than one hospital or medical school team work on a medical research study), Phase 3 trial to evaluate the efficacy and safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS.
Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group.
Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks.
Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment.
Efficacy will be assessed primarily by evaluating progression-free survival (PFS).
Participants' safety will be monitored throughout the trial.
Study Type
Interventional
Enrollment (Actual)
121
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Boreaux, France
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Lille, France
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Lyon, France
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Paris, France
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Villejuif, France
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Bad Saarow, Germany
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Köln, Germany
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Mannheim, Germany
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Barcelona, Spain
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Palma De Mallorca N/A, Spain
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Valencia N/A, Spain
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Edinburgh, United Kingdom
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Glasgow, United Kingdom
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London, United Kingdom
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Manchester, United Kingdom
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California
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Santa Monica, California, United States
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Massachusetts
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Boston, Massachusetts, United States
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New Mexico
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Albuquerque, New Mexico, United States
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Pennsylvania
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Philadelphia, Pennsylvania, United States
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Texas
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Houston, Texas, United States
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Utah
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Salt Lake City, Utah, United States
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Pathological diagnosis of translocation-related sarcomas (TRS) including the following subtypes: alveolar soft part sarcoma, angiomatoid fibrous histiocytoma, clear cell sarcoma, desmoplastic small round cell tumor, low grade endometrial stromal sarcoma (prior hormone therapy allowed), low grade fibromyxoid sarcoma, myxoid chondrosarcoma, myxoid/round cell liposarcoma (MRCL) and synovial sarcoma
- Participants must have unresectable locally advanced or metastatic progressive disease prior to enrolment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2
- Adequate cardiac function, defined as left ventricular ejection fraction (LVEF) within normal limits according to institutional standards, as shown by echocardiography or scintigraphy multiple-gated acquisition scan [MUGA]
- Measurable disease as defined by the radiological (computed tomography [CT] scan and magnetic resonance imaging [MRI]) Response Evaluation Criteria in Solid Tumors (RECIST v.1.0) guidelines
Exclusion Criteria:
- Known hypersensitivity to any components of the intravenous formulation of trabectedin or the comparators
- Prior chemotherapy treatment or irradiation of the lesion if only one target lesion is available
- Brain metastases and/or leptomeningeal metastases, even if treated
- Pregnant or lactating women or men and women of reproductive potential who are not using effective contraceptive methods
- History of another neoplastic disease (except basal cell carcinoma or cervical carcinoma in situ adequately treated) unless in remission for five years or more
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Trabectedin
Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
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Trabectedin 1.5 milligram per square meter (mg/m^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.
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Active Comparator: Doxorubicin plus Ifosfamide
Doxorubicin (as a monotherapy) 75 mg per m^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m^2 every 3 weeks until disease progression.
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Doxorubicin 60 or 75 mg/m^2 will be given intravenously every 3 weeks until disease progression.
Ifosfamide 6 to 9 g/m^2 will be given intravenously every 3 weeks until disease progression.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Progression - Free Survival (PFS)
Time Frame: Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months
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The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.
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Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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6-month Progression - Free Survival
Time Frame: 6 months
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Percentage of participants survived for 6 months from the start of study treatment without progression of disease.
Progression of the disease was associated with increasing symptoms, including pain from new or progressing lesions.
Delay in disease progression generally represents a clinical benefit to the participant.
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6 months
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Percentage of Participants With Objective Response
Time Frame: Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months
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Tumor response was assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) criteria: Partial Response (PR)=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, Complete Response (CR) =Disappearance of all non-target lesions.
Percentage of participants with objective tumor response was determined by the number of participants with PR or CR divided by the total number of response-evaluable participants.
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Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months
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Overall Survival
Time Frame: Baseline up to End of Study (an average of 4 years)
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Overall survival defined as time from the date of randomization to the date of death.
For participants who were alive at the time of analysis, overall survival was censored at the last contact date.
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Baseline up to End of Study (an average of 4 years)
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Duration of Response (DOR)
Time Frame: Up to 20 months
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The DOR is defined as the time from date of first documentation of response (CR or PR, whichever comes first) to the date of documented PD or death.
PR=at least 30% reduction in the sum of the longest dimensions (LD) of all target lesions in reference to the baseline sum LD, CR =Disappearance of all non-target lesions.
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Up to 20 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2008
Primary Completion (Actual)
August 1, 2012
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
November 20, 2008
First Submitted That Met QC Criteria
November 20, 2008
First Posted (Estimate)
November 24, 2008
Study Record Updates
Last Update Posted (Estimate)
December 10, 2015
Last Update Submitted That Met QC Criteria
December 9, 2015
Last Verified
December 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms, Connective and Soft Tissue
- Neoplasms by Histologic Type
- Neoplasms
- Sarcoma
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Topoisomerase II Inhibitors
- Topoisomerase Inhibitors
- Antibiotics, Antineoplastic
- Ifosfamide
- Doxorubicin
- Trabectedin
Other Study ID Numbers
- CR015769
- ET-C-002-07 (Other Identifier: Johnson & Johnson Pharmaceutical Research and Development, L.L.C.)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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