A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
18 Years
N/A
Both
Translocation, Genetic, Sarcoma, Soft Tissue
Trial Information
A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)
This is a randomized (patients will be assigned to treatment by chance), multicenter, Phase
III trial to evaluate the effectiveness of trabectedin versus standard doxorubicin-based
chemotherapy (DXCT) as first-line treatment of patients with advanced Translocation-Related
Sarcomas (TRS) (a type of cancer), by comparing progression-free survival (PFS) in the two
treatment arms (Treatment Arm A: Trabectedin; Treatment Arm B: Doxorubicin as a single agent
or in combination with ifosfamide). Trabectedin 1.5 mg/m2 given intravenously (i.v.) over
24-hours; or doxorubicin 75 mg/m2 i.v. every 3 weeks, or doxorubicin 60 mg/m2 i.v.followed
by ifosfamide in the range of 6 to 9 g/m2 every 3 weeks with proper hydration and ifosfamide
chemoprotectant drugs.
Inclusion Criteria:
- Pathological diagnosis of TRS (institutional assessment)
- Patients must have unresectable locally advanced or metastatic disease prior to
enrollment
- Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0-2
- Adequate cardiac function.
Exclusion Criteria:
- Known hypersensitivity to any components of the i.v. formulation of trabectedin or
the comparator
- Prior chemotherapy treatment of irradiation of the lesion
- Brain metastases and/or leptomeningeal metastases, even if treated
- Pregnant or lactating women
- History of another neoplastic disease unless in remission for five years or more.
Other serious illnesses such as congestive heart failure or angina pectoris,
myocardial infarction within 1 year before enrollment, uncontrolled arterial
hypertension or arrhythmias.
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Progression - Free Survival
Outcome Time Frame:
Up to approximately 20 months
Safety Issue:
No
Principal Investigator
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
Investigator Role:
Study Director
Investigator Affiliation:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Authority:
United States: Food and Drug Administration
Study ID:
CR015769
NCT ID:
NCT00796120
Start Date:
November 2008
Completion Date:
July 2011
Related Keywords:
- Translocation, Genetic
- Sarcoma, Soft Tissue
- Soft Tissue Sarcomas
- Translocation-Related Sarcomas (TRS)
- Translocation, Genetic
- Sarcoma
Name | Location |
|---|---|
| Fountain Valley, California 92708 | |
| Philadelphia, Pennsylvania 19104 | |
| Austin, Texas 78705 | |
| Albuquerque, New Mexico 87131-5636 | |
| Boston, Massachusetts |
