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

NCT00796120 | Completed Phase 3 Results

• 2 other identifiers: CR015769ET-C-002-07
• Study Type: interventional
• Target: 121
• Locations: 5 countries
• Sites: 21

Brief Summary

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).

Conditions

Sarcoma

Keywords

Sarcomas; Trabectedin; Doxorubicin; Ifosfamide; YONDELIS

Outcome Measures

Primary Outcomes (1)

• Progression - Free Survival (PFS)

  The PFS was assessed as median number of days from the date of randomization until the first documented sign of disease progression (increase in disease; radiographic, clinical, or both) or death due to any cause, whichever occurred earlier.

  Every 6 weeks from randomization during the first 9 months and thereafter, every 9 weeks up to 20 months

Secondary Outcomes (4)

• 6-month Progression - Free Survival

  6 months

• Percentage of Participants With Objective Response

  Every 6 weeks during first 9 months of the study and thereafter every 9 weeks up to 20 months

• Overall Survival

  Baseline up to End of Study (an average of 4 years)

• Duration of Response (DOR)

  Up to 20 months

Study Arms (2)

Trabectedin

EXPERIMENTAL

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.

Drug: Trabectedin

Doxorubicin plus Ifosfamide

ACTIVE COMPARATOR

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.

Drug: Doxorubicin; Drug: Ifosfamide

Interventions

Trabectedin 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.

Trabectedin

Doxorubicin DRUG

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

Doxorubicin plus Ifosfamide

Ifosfamide DRUG

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

Doxorubicin plus Ifosfamide

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• PharmaMar: collaborator

Study Sites (21)

Unknown Facility

Santa Monica, California, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

Albuquerque, New Mexico, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, United States

Location

Unknown Facility

Houston, Texas, United States

Location

Unknown Facility

Salt Lake City, Utah, United States

Location

Unknown Facility

Boreaux, France

Location

Unknown Facility

Lille, France

Location

Unknown Facility

Lyon, France

Location

Unknown Facility

Paris, France

Location

Unknown Facility

Villejuif, France

Location

Unknown Facility

Bad Saarow, Germany

Location

Unknown Facility

Cologne, Germany

Location

Unknown Facility

Mannheim, Germany

Location

Unknown Facility

Barcelona, Spain

Location

Unknown Facility

Palma, Spain

Location

Unknown Facility

Valencia, Spain

Location

Unknown Facility

Edinburgh, United Kingdom

Location

Unknown Facility

Glasgow, United Kingdom

Location

Unknown Facility

London, United Kingdom

Location

Unknown Facility

Manchester, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24512981 DERIVED

MeSH Terms

Conditions

Sarcoma

Interventions

Trabectedin; Doxorubicin; Ifosfamide

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms

Intervention Hierarchy (Ancestors)

Dioxoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Tetrahydroisoquinolines; Isoquinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Cyclophosphamide; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds; Oxazines

Results Point of Contact

• Title: Medical Specialist, Clinical Oncology
• Organization: PharmaMar SA Av de los Reyes 1, Poligono Industrial La Mina 28770 Colmenar Viejo, Madrid, Spain

+34 91 646-6087

Study Officials

• Johnson & Johnson Pharmaceutical Research & Development, LLC Clinical Trial

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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 20, 2008
• First Posted: November 24, 2008
• Study Start: November 1, 2008
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2014
• Last Updated: December 10, 2015
• Results First Posted: September 16, 2014

Record last verified: 2015-12

Locations

ES (3); FR (5); GB (4); DE (3); US (6)