Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
NCT ID: NCT00061984
Last Updated: 2014-10-27
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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COMPLETED
PHASE3
455 participants
INTERVENTIONAL
2003-04-30
2012-07-31
Brief Summary
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PURPOSE: This randomized phase III trial is studying giving doxorubicin alone to see how well it works compared to giving doxorubicin together with ifosfamide and pegfilgrastim in treating patients with locally advanced or metastatic soft tissue sarcoma.
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Detailed Description
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* Compare the progression-free and overall survival of patients with locally advanced or metastatic soft tissue sarcoma treated with doxorubicin with vs without ifosfamide and pegfilgrastim as first-line therapy.
* Compare the response in patients treated with these regimens.
* Compare the treatment-related mortality of patients treated with these regimens.
* Compare the toxicity of these regimens in these patients.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified according to WHO performance status (0 vs 1), age group (less than 50 years of age vs 50 years of age and over), presence of liver metastases (yes vs no), histological grade (2 vs 3), and participating center. Patients are randomized to 1 of 2 treatment arms.
* Arm I: Patients receive doxorubicin IV on day 1 (or IV continuously on days 1-3).
* Arm II: Patients receive doxorubicin IV on days 1-3 and ifosfamide IV over 4 hours on days 1-4. Patients also receive pegfilgrastim subcutaneously on day 5.
In both arms, treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity.
Patients are followed every 8 weeks until disease progression and then every 12 weeks thereafter.
PROJECTED ACCRUAL: A total of 450 patients will be accrued for this study within 4 years.
Conditions
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Study Design
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RANDOMIZED
TREATMENT
NONE
Interventions
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pegfilgrastim
doxorubicin hydrochloride
ifosfamide
multimodality therapy
Eligibility Criteria
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Inclusion Criteria
* Myxoid and round cell liposarcoma, pleomorphic liposarcoma, or dedifferentiated liposarcoma
* Pleomorphic rhabdomyosarcoma
* Synovial sarcoma
* Myxofibrosarcoma, intermediate and high-grade
* Fibrosarcoma
* Leiomyosarcoma
* Angiosarcoma
* Malignant peripheral nerve sheath tumor
* Epithelioid sarcoma
* Alveolar rhabdomyosarcoma
* Unclassifiable sarcoma, not otherwise specified
* The following tumor types are not eligible:
* Gastrointestinal stromal tumor
* Mixed mesodermal tumor
* Chondrosarcoma
* Malignant mesothelioma
* Neuroblastoma
* Osteosarcoma
* Ewing's sarcoma/primitive neuroectodermal tumor
* Desmoplastic small round cell tumor
* Embryonal rhabdomyosarcoma
* Alveolar soft part sarcoma
* Must have a measurable lesion with clinical evidence of progression within the past 6 weeks
* Osseous lesions and pleural effusions are not considered measurable
* No known or symptomatic CNS metastases
PATIENT CHARACTERISTICS:
Age
* 18 to 60
Performance status
* WHO 0-1
Life expectancy
* Not specified
Hematopoietic
* Absolute neutrophil count at least 2,000/mm\^3
* Platelet count at least 100,000/mm\^3
Hepatic
* Bilirubin no greater than 1.8 mg/dL
* Albumin at least 2.5 g/dL
Renal
* Creatinine no greater than 1.4 mg/dL OR
* Creatinine clearance greater than 65 mL/min
Cardiovascular
* No history of cardiovascular disease
Other
* Not pregnant
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other severe medical illness
* No psychosis
* No other prior or concurrent malignancy except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
* No psychological, familial, sociological, or geographical condition that would preclude study compliance and follow-up schedule
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* No prior chemotherapy for advanced or metastatic disease
* Prior adjuvant chemotherapy allowed provided there was no disease progression within 6 months after completion of treatment
Endocrine therapy
* Not specified
Radiotherapy
* No prior radiotherapy to the sole index lesion
Surgery
* Not specified
18 Years
60 Years
ALL
No
Sponsors
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European Organisation for Research and Treatment of Cancer - EORTC
NETWORK
Responsible Party
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Principal Investigators
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Ian R. Judson, MA, MD, FRCP
Role: STUDY_CHAIR
Institute of Cancer Research, United Kingdom
Locations
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Cross Cancer Institute at University of Alberta
Edmonton, Alberta, Canada
Doctor H. Bliss Murphy Cancer Centre
St. John's, Newfoundland and Labrador, Canada
Karl-Franzens-University Graz
Graz, , Austria
Institut Jules Bordet
Brussels, , Belgium
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
U.Z. Gasthuisberg
Leuven, , Belgium
Tom Baker Cancer Centre - Calgary
Calgary, Alberta, Canada
Margaret and Charles Juravinski Cancer Centre
Hamilton, Ontario, Canada
McGill Cancer Centre at McGill University
Montreal, Quebec, Canada
Aarhus Universitetshospital - Aarhus Sygehus
Aarhus, , Denmark
Copenhagen County Herlev University Hospital
Copenhagen, , Denmark
Institut Bergonie
Bordeaux, , France
Centre Leon Berard
Lyon, , France
CHU de la Timone
Marseille, , France
Medizinische Universitaetsklinik I at the University of Cologne
Cologne, , Germany
Universitatsklinikum Carl Gustav Carus
Dresden, , Germany
Universitaetsklinikum Essen
Essen, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Klinikum der Stadt Mannheim
Mannheim, , Germany
Klinikum der Universitaet Muenchen - Grosshadern Campus
Munich, , Germany
Southwest German Cancer Center at Eberhard-Karls-University
Tübingen, , Germany
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, , Netherlands
University Medical Center Groningen
Groningen, , Netherlands
Leiden University Medical Center
Leiden, , Netherlands
Universitair Medisch Centrum St. Radboud - Nijmegen
Nijmegen, , Netherlands
University Medical Center Rotterdam at Erasmus Medical Center
Rotterdam, , Netherlands
National Cancer Institute - Bratislava
Bratislava, , Slovakia
Vall d'Hebron University Hospital
Barcelona, , Spain
Hospital Universitario San Carlos
Madrid, , Spain
Centre Hospitalier Universitaire Vaudois
Lausanne, , Switzerland
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom
Leeds Cancer Centre at St. James's University Hospital
Leeds, England, United Kingdom
Royal Marsden - London
London, England, United Kingdom
University College of London Hospitals
London, England, United Kingdom
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle upon Tyne, England, United Kingdom
Derriford Hospital
Plymouth, England, United Kingdom
Cancer Research Centre at Weston Park Hospital
Sheffield, England, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom
Western Infirmary
Glasgow, Scotland, United Kingdom
Gartnavel General Hospital
Glasgow, Scotland, United Kingdom
Countries
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References
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Judson I, Verweij J, Gelderblom H, Hartmann JT, Schoffski P, Blay JY, Kerst JM, Sufliarsky J, Whelan J, Hohenberger P, Krarup-Hansen A, Alcindor T, Marreaud S, Litiere S, Hermans C, Fisher C, Hogendoorn PC, dei Tos AP, van der Graaf WT; European Organisation and Treatment of Cancer Soft Tissue and Bone Sarcoma Group. Doxorubicin alone versus intensified doxorubicin plus ifosfamide for first-line treatment of advanced or metastatic soft-tissue sarcoma: a randomised controlled phase 3 trial. Lancet Oncol. 2014 Apr;15(4):415-23. doi: 10.1016/S1470-2045(14)70063-4. Epub 2014 Mar 5.
Other Identifiers
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EORTC-62012
Identifier Type: -
Identifier Source: secondary_id
EORTC-62012
Identifier Type: -
Identifier Source: org_study_id
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