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An Efficacy and Safety Study of Trabectedin Versus Doxorubicin-Based Chemotherapy in Participants With Translocation-Related Sarcomas (TRS)

NCT ID: NCT00796120

Last Updated: 2015-12-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-11-30

Study Completion Date

2014-08-31

Brief Summary

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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 tissue cells) (TRS).

Detailed Description

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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 safety of trabectedin as compared to standard doxorubicin in participants with advanced TRS. Participants will be randomized in a 1:1 ratio to either of the 2 treatment groups, that is, trabectedin or doxorubicin plus ifosfamide group. Participants in trabectedin group will receive trabectedin 1.5 milligram per square meter (mg/m\^2) given as a 24-hour continuous intravenous infusion (a fluid or a medicine delivered into a vein by way of a needle) every 3 weeks and in doxorubicin plus ifosfamide group participants will receive doxorubicin 60 or 75 mg/m\^2 intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks. Participants in either treatment arm will continue receiving therapy in the absence of progressive disease (PD) or intolerable side effects, until the participants' consent is withdrawn or the eligibility criteria for continuing treatment are no longer fulfilled, or when a concurrent condition precludes continuation of treatment. Efficacy will be assessed primarily by evaluating progression-free survival (PFS). Participants' safety will be monitored throughout the trial.

Conditions

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Sarcoma

Keywords

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Sarcomas Trabectedin Doxorubicin Ifosfamide YONDELIS

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Trabectedin

Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

Group Type EXPERIMENTAL

Trabectedin

Intervention Type DRUG

Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

Doxorubicin plus Ifosfamide

Doxorubicin (as a monotherapy) 75 mg per m\^2 will be given intravenously every 3 weeks or Doxorubicin 60 mg per m\^2 will be given intravenously every 3 weeks followed by ifosfamide 6 to 9 gram (g)/m\^2 every 3 weeks until disease progression.

Group Type ACTIVE_COMPARATOR

Doxorubicin

Intervention Type DRUG

Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.

Ifosfamide

Intervention Type DRUG

Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.

Interventions

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Trabectedin

Trabectedin 1.5 milligram per square meter (mg/m\^2) will be given as 24-hour continuous intravenous infusion every 3 weeks until disease progression.

Intervention Type DRUG

Doxorubicin

Doxorubicin 60 or 75 mg/m\^2 will be given intravenously every 3 weeks until disease progression.

Intervention Type DRUG

Ifosfamide

Ifosfamide 6 to 9 g/m\^2 will be given intravenously every 3 weeks until disease progression.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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 Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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PharmaMar

INDUSTRY

Sponsor Role collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

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Santa Monica, California, United States

Site Status

Boston, Massachusetts, United States

Site Status

Albuquerque, New Mexico, United States

Site Status

Philadelphia, Pennsylvania, United States

Site Status

Houston, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Boreaux, , France

Site Status

Lille, , France

Site Status

Lyon, , France

Site Status

Paris, , France

Site Status

Villejuif, , France

Site Status

Bad Saarow, , Germany

Site Status

Cologne, , Germany

Site Status

Mannheim, , Germany

Site Status

Barcelona, , Spain

Site Status

Palma, , Spain

Site Status

Valencia, , Spain

Site Status

Edinburgh, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Countries

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United States France Germany Spain United Kingdom

References

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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.

Reference Type DERIVED
PMID: 24512981 (View on PubMed)

Other Identifiers

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ET-C-002-07

Identifier Type: OTHER

Identifier Source: secondary_id

CR015769

Identifier Type: -

Identifier Source: org_study_id