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
  Purpose

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).


Condition Intervention Phase
Translocation, Genetic
Sarcoma, Soft Tissue
Drug: Trabectedin
Drug: Doxorubicin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized, Multicenter, Phase III Trial of Trabectedin (Yondelis) Versus Doxorubicin-based Chemotherapy as First-Line Therapy in Patients With Translocation-Related Sarcomas (TRS)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:

Primary Outcome Measures:
  • Progression - Free Survival [ Time Frame: Up to approximately 20 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 80
Study Start Date: November 2008
Study Completion Date: July 2011
Arms Assigned Interventions
Experimental: 001
Trabectedin 1.5 mg/m2 administered as a 24-hour i.v. infusion every three weeks
Drug: Trabectedin
1.5 mg/m2 administered as a 24-hour i.v. infusion every three weeks
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
Drug: Doxorubicin
75 mg/m2 i.v. every three weeks

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796120

Locations
United States, California
Santa Monica, California, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, New Mexico
Albuquerque, New Mexico, United States
United States, Pennsylvania
Philadelphia, Pennsylvania, United States
United States, Texas
Houston, Texas, United States
France
Boreaux, France
Lille, France
Lyon, France
Paris, France
Villejuif, France
Germany
Bad Saarow, Germany
Köln, Germany
Mannheim, Germany
Spain
Barcelona, Spain
Palma De Mallorca N/A, Spain
Valencia N/A, Spain
United Kingdom
Edinburgh, United Kingdom
Glasgow, United Kingdom
London, United Kingdom
Manchester, United Kingdom
Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
PharmaMar
Investigators
Study Director: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
  More Information

No publications provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Sr. Director Compound Development Team Leader, Johnson & Johnson Pharmaceutical Research and Development, L.L.C.
ClinicalTrials.gov Identifier: NCT00796120     History of Changes
Other Study ID Numbers: CR015769, ET-C-002-07
Study First Received: November 20, 2008
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Johnson & Johnson Pharmaceutical Research & Development, L.L.C.:
Soft Tissue Sarcomas
Translocation-Related Sarcomas (TRS)

Additional relevant MeSH terms:
Translocation, Genetic
Sarcoma
Chromosome Aberrations
Pathologic Processes
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms
Doxorubicin
Liposomal doxorubicin
Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Alkylating
Alkylating Agents

ClinicalTrials.gov processed this record on August 28, 2014