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

Sponsor:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Collaborator:	PharmaMar
Information provided by:	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
ClinicalTrials.gov Identifier:	NCT00796120

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:

Genetics Home Reference related topics: 17q21.31 microdeletion syndrome tetrasomy 18p

MedlinePlus related topics: Soft Tissue Sarcoma

Drug Information available for: Doxorubicin Doxorubicin hydrochloride

U.S. FDA Resources

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 ]

Estimated Enrollment:	80
Study Start Date:	November 2008

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

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

Contacts

Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions:

JNJ.CT@sylogent.com

Locations

United States, California
	Recruiting
Santa Monica, California, United States
United States, Massachusetts
	Recruiting
Boston, Massachusetts, United States
United States, New Mexico
	Completed
Albuquerque, New Mexico, United States
United States, Pennsylvania
	Completed
Philadelphia, Pennsylvania, United States
United States, Texas
	Recruiting
Houston, Texas, United States
France
	Recruiting
Boreaux, France
	Recruiting
Lille, France
	Recruiting
Lyon, France
	Recruiting
Paris, France
	Recruiting
Villejuif, France
Germany
	Recruiting
Bad Saarow, Germany
	Recruiting
Köln, Germany
	Recruiting
Mannheim, Germany
Spain
	Completed
Barcelona, Spain
	Recruiting
Palma De Mallorca N/A, Spain
	Completed
Valencia N/A, Spain
United Kingdom
	Recruiting
Edinburgh, United Kingdom
	Recruiting
Glasgow, United Kingdom
	Recruiting
London, United Kingdom
	Withdrawn
London, United Kingdom
	Recruiting
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

Additional Information:

To learn how to participate in this trial please click here. This link exits the ClinicalTrials.gov site

No publications provided

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:	May 16, 2012
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

Trabectedin
Antibiotics, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 23, 2012