A Study of the Safety and Effectiveness of Trabetedin Versus Doxorubicin-based Chemotherapy in Patients With Translocation-Related Sarcomas (TRS)

This study has been completed.
Sponsor:
Collaborator:
PharmaMar
Information provided by:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:
NCT00796120
First received: November 20, 2008
Last updated: April 18, 2013
Last verified: April 2013

November 20, 2008
April 18, 2013
November 2008
Not Provided
Progression - Free Survival [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]
To evaluate the effectiveness of trabetedin compared to standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced TRS, by comparing progression-free survival (PFS).
Complete list of historical versions of study NCT00796120 on ClinicalTrials.gov Archive Site
  • Progression - Free Survival [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]
  • Best objective response [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: Yes ]
To compare; PFS at 6 months, response rates and duration of response, exploratory evaluations using Choi response criteria, PFS and RR in subgroups of patients stratified by histological type, overall survival and safety profile in each arm
Not Provided
Not Provided
 
A Study of the Safety and Effectiveness of Trabetedin Versus Doxorubicin-based Chemotherapy in Patients With Translocation-Related Sarcomas (TRS)
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 effectiveness of trabetedin compared to standard doxorubicin-based chemotherapy as first-line treatment in patients with advanced Translocation-Related Sarcomas (a type of cancer).

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Translocation, Genetic
  • Sarcoma, Soft Tissue
  • Drug: Trabectedin
    1.5 mg/m2 administered as a 24-hour i.v. infusion every three weeks
  • Drug: Doxorubicin
    75 mg/m2 i.v. every three weeks
  • Experimental: 001
    Trabectedin 1.5 mg/m2 administered as a 24-hour i.v. infusion every three weeks
    Intervention: Drug: Trabectedin
  • Active Comparator: 002
    Doxorubicin 75 mg/m2 i.v. every three weeks or 60 mg/m2 i.v. followed by ifosfamide range 6 to 9 g/m2 i.v.every three weeks
    Intervention: Drug: Doxorubicin
Blay JY, Leahy MG, Nguyen BB, Patel SR, Hohenberger P, Santoro A, Staddon AP, Penel N, Piperno-Neumann S, Hendifar A, Lardelli P, Nieto A, Alfaro V, Chawla SP. Randomised phase III trial of trabectedin versus doxorubicin-based chemotherapy as first-line therapy in translocation-related sarcomas. Eur J Cancer. 2014 Apr;50(6):1137-47. doi: 10.1016/j.ejca.2014.01.012. Epub 2014 Feb 7.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2011
Not Provided

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   France,   Germany,   Spain,   United Kingdom
 
NCT00796120
CR015769, ET-C-002-07
Not Provided
Sr. Director Compound Development Team Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP