Status:
COMPLETED
An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)
Lead Sponsor:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborating Sponsors:
PharmaMar
Conditions:
Sarcoma
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
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 tiss...
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 safe...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
121 Patients enrolled
Trial Details
Trial ID
NCT00796120
Start Date
November 1 2008
End Date
August 1 2014
Last Update
December 10 2015
Active Locations (21)
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1
Santa Monica, California, United States
2
Boston, Massachusetts, United States
3
Albuquerque, New Mexico, United States
4
Philadelphia, Pennsylvania, United States