Doxorubicin Hydrochloride or Trabectedin in Treating Patients With Previously Untreated Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT01189253
Last Updated: 2014-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2/PHASE3
133 participants
INTERVENTIONAL
2011-05-31
2015-06-30
Brief Summary
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PURPOSE: This randomized phase II/III trial is studying the safety of trabectedin compared with doxorubicin hydrochloride and to see how well they work in treating patients with advanced or metastatic soft tissue sarcoma.
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Detailed Description
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* To evaluate whether trabectedin given as first-line chemotherapy for patients with previously untreated advanced or metastatic malignant soft tissue sarcoma prolongs progression-free survival as compared to doxorubicin hydrochloride.
* To identify and validate biomarkers (including, but not limited to, XPG, BRCA1, RAD51, BRCA2, ATM and CHK1) of sensitivity to trabectedin in order to allow the selection of patients that benefit most from trabectedin treatment. (Optional translational research)
OUTLINE: This is a multicenter, phase IIB study followed by a phase III study. Patients are stratified according to institution, age at registration (\< 60 years old vs ≥ 60 years old), and presence of liver metastases (yes vs no).
* Phase IIB (step 1): Patients are randomized to 1 of 3 treatment arms.
* Arm I: Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive trabectedin IV over 3 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm III: Patients receive trabectedin IV continuously over 24 hours on day 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
At the end of step 1, the best regimen of trabectedin will be determined. Patients receiving the non-selected trabectedin regimen ("losing arm") are offered to cross over in order to receive the selected regimen of trabectedin.
* Phase III (step 2): Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive trabectedin IV on day 1 using the preferred regimen determined in step 1. Courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity.
* Arm II: Patients receive doxorubicin hydrochloride IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
Patients complete quality of life questionnaire (EORTC QLQ-C30 version 3) at baseline, at 6, 12, 24, and 36 weeks during study, and at the end of study.
Tumor tissue block obtained at diagnosis may be analyzed to identify and validate biomarkers of sensitivity to trabectedin and for tissue microarrays.
After completion of study therapy, patients are followed up at 1 month, every 6 or 12 weeks until disease progression, and every 12 weeks thereafter.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Doxorubicin 75 mg/m² every 3 weeks
Doxorubicin administered on day 1 every 3 weeks for a maximum of 6 cycles
doxorubicin hydrochloride
laboratory biomarker analysis
quality-of-life assessment
Trabectedin IV 3 hours
Trabectedin administered on day 1 every 3 weeks at the dose of 1.3 mg/m² until progression
trabectedin
laboratory biomarker analysis
quality-of-life assessment
Trabectedin IV 24 hours every 3 weeks
Trabectedin administered on day 1 every 3 weeks at the dose of 1.5 mg/m² over 24 hours until progression
trabectedin
laboratory biomarker analysis
quality-of-life assessment
Interventions
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doxorubicin hydrochloride
trabectedin
laboratory biomarker analysis
quality-of-life assessment
Eligibility Criteria
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Inclusion Criteria
* No psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* No concurrent alcohol consumption
PRIOR CONCURRENT THERAPY:
* See Disease Characteristics
* At least 28 days since prior and no concurrent anticancer therapy including systemic therapy, radiotherapy, or surgery
* At least 28 days since prior and no other concurrent investigational agents
* No concurrent phenytoin, live attenuated vaccines, or yellow fever vaccine
18 Years
ALL
No
Sponsors
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Sarcoma Alliance for Research through Collaboration
OTHER
European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Nguyen Binh Bui, MD
Role: STUDY_CHAIR
Institut Bergonié
James E. Butrynski, MD
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Locations
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Sarcoma Oncology Center
Santa Monica, California, United States
Stanford Hospital and Clinics
Stanford, California, United States
Holden Comprehensive Cancer Center at University of Iowa
Iowa City, Iowa, United States
Dana Farber Institute
Boston, Massachusetts, United States
Massachussets General Hospital
Boston, Massachusetts, United States
Methodist Estabrook Cancer Center
Omaha, Nebraska, United States
Carolinas Hematology-Oncology Associates
Charlotte, North Carolina, United States
Pennsylvania Oncology Hematology Associates, Incorporated - Philadelphia
Philadelphia, Pennsylvania, United States
Medical University Vienna
Vienna, , Austria
HôPITAUX UNIVERSITAIRES BORDET-ERASME - INSTITUT JULES BORDET
Brussels, , Belgium
Cliniques Universitaires St. Luc
Brussels, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Aarhus University Hospital
Aarhus, , Denmark
Herlev Hospital - University Copenhagen
Herlev, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Georges-Francois-Leclerc
Dijon, , France
Centre Oscar Lambret
Lille, , France
Centre Leon Berard
Lyon, , France
ASSISTANCE PUBLIQUE - HôPITAUX DE MARSEILLE - HôPITAL DE LA TIMONE
Marseille, , France
Institut de Cancerologie de L'Ouest (Ico) - Centre Rene Gauducheau
Nantes - Saint Herblain, , France
Institut Curie
Paris, , France
Institut Gustave Roussy
Villejuif, , France
Helios Klinikum Bad Saarow
Bad Saarow, , Germany
Universitaetsklinikum Koeln
Cologne, , Germany
Universitaetsklinikum Carl Gustav Carus
Dresden, , Germany
Universitaets-Krankenhaus Eppendorf
Hamburg, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Universitaetsmedizin Mannheim
Mannheim, , Germany
Klinikum Grosshadern Ludwig-Maximilians Univ. Muenchen
München, , Germany
Military Hospital - State Health Centre
Budapest, , Hungary
The Netherlands Cancer Institute-Antoni Van Leeuwenhoekziekenhuis
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Centre
Leiden, , Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, , Netherlands
Erasmus Mc - Daniel Den Hoed Cancer Center
Rotterdam, , Netherlands
Maria Sklodowska-Curie Memorial Cancer Centre
Warsaw, , Poland
National Cancer Institute
Bratislava, , Slovakia
Hospital General Vall D'Hebron
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Nhs Greater Glasgow and Clyde - Beatson West of Scotland Cancer Centre
Glasgow, , United Kingdom
Christie Nhs Foundation Trust
Manchester, , United Kingdom
Nottingham University Hospitals Nhs Trust - City Hospital Campus
Nottingham, , United Kingdom
Countries
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Other Identifiers
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EORTC-62091
Identifier Type: -
Identifier Source: secondary_id
2009-014889-26
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EU-21059
Identifier Type: -
Identifier Source: secondary_id
PMAR-EORTC-62091
Identifier Type: -
Identifier Source: secondary_id
SARC-020
Identifier Type: -
Identifier Source: secondary_id
EORTC-62091
Identifier Type: -
Identifier Source: org_study_id
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