Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

NCT00061984 | Completed Phase 3

• 1 other identifier: EORTC-62012
• Study Type: interventional
• Target: 455
• Locations: 11 countries
• Sites: 41

Brief Summary

RATIONALE: Drugs used in chemotherapy such as doxorubicin and ifosfamide use different ways to stop tumor cells from dividing so they stop growing or die. Colony-stimulating factors, such as pegfilgrastim, cause the body to make blood cells. It is not yet known whether doxorubicin alone is more effective with or without ifosfamide and pegfilgrastim in treating soft tissue sarcoma. 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.

Conditions

Sarcoma

Keywords

adult angiosarcoma; adult epithelioid sarcoma; adult fibrosarcoma; adult leiomyosarcoma; adult liposarcoma; adult rhabdomyosarcoma; adult synovial sarcoma; stage III adult soft tissue sarcoma; adult malignant fibrous histiocytoma; adult neurofibrosarcoma; stage II adult soft tissue sarcoma; stage IV adult soft tissue sarcoma

Outcome Measures

Primary Outcomes (1)

• Overall survival

Secondary Outcomes (3)

• Response as assessed by RECIST criteria

• Toxicity as assessed by CTC 2.0

• Treatment-related mortality

Interventions

pegfilgrastim BIOLOGICAL

doxorubicin hydrochloride DRUG

ifosfamide DRUG

multimodality therapy PROCEDURE

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically confirmed soft tissue sarcoma * Locally advanced unresectable\* OR metastatic disease * High-grade (grade 2-3) disease according to the FNLCC grading system NOTE: \*Disease that could prove resectable (including pulmonary metastasectomy) after a response to chemotherapy is allowed * The following tumor types are eligible: * Malignant fibrous histiocytoma * 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC: lead

Study Sites (41)

Karl-Franzens-University Graz

Graz, A-8010, Austria

Location

Institut Jules Bordet

Brussels, 1000, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, B-2650, Belgium

Location

U.Z. Gasthuisberg

Leuven, B-3000, Belgium

Location

Tom Baker Cancer Centre - Calgary

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute at University of Alberta

Edmonton, Alberta, T6G 1Z2, Canada

Location

Doctor H. Bliss Murphy Cancer Centre

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Margaret and Charles Juravinski Cancer Centre

Hamilton, Ontario, L8V 5C2, Canada

Location

McGill Cancer Centre at McGill University

Montreal, Quebec, H3G 1Y6, Canada

Location

Aarhus Universitetshospital - Aarhus Sygehus

Aarhus, DK-8000, Denmark

Location

Copenhagen County Herlev University Hospital

Copenhagen, DK-2730, Denmark

Location

Institut Bergonie

Bordeaux, 33076, France

Location

Centre Leon Berard

Lyon, 69373, France

Location

CHU de la Timone

Marseille, 13385, France

Location

Medizinische Universitaetsklinik I at the University of Cologne

Cologne, D-50924, Germany

Location

Universitatsklinikum Carl Gustav Carus

Dresden, D-01307, Germany

Location

Universitaetsklinikum Essen

Essen, D-45122, Germany

Location

Medizinische Hochschule Hannover

Hanover, D-30625, Germany

Location

Klinikum der Stadt Mannheim

Mannheim, D-68135, Germany

Location

Klinikum der Universitaet Muenchen - Grosshadern Campus

Munich, D-81377, Germany

Location

Southwest German Cancer Center at Eberhard-Karls-University

Tübingen, D-72076, Germany

Location

Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

Amsterdam, 1066 CX, Netherlands

Location

University Medical Center Groningen

Groningen, 9700 RB, Netherlands

Location

Leiden University Medical Center

Leiden, 2300 CA, Netherlands

Location

Universitair Medisch Centrum St. Radboud - Nijmegen

Nijmegen, NL-6500 HB, Netherlands

Location

University Medical Center Rotterdam at Erasmus Medical Center

Rotterdam, 3000 CA, Netherlands

Location

National Cancer Institute - Bratislava

Bratislava, 833 10, Slovakia

Location

Vall d'Hebron University Hospital

Barcelona, 08035, Spain

Location

Hospital Universitario San Carlos

Madrid, 28040, Spain

Location

Centre Hospitalier Universitaire Vaudois

Lausanne, CH-1011, Switzerland

Location

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

Birmingham, England, B15 2TH, United Kingdom

Location

Leeds Cancer Centre at St. James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Royal Marsden - London

London, England, SW3 6JJ, United Kingdom

Location

University College of London Hospitals

London, England, WIT 3AA, United Kingdom

Location

Northern Centre for Cancer Treatment at Newcastle General Hospital

Newcastle upon Tyne, England, NE4 6BE, United Kingdom

Location

Derriford Hospital

Plymouth, England, PL6 8DH, United Kingdom

Location

Cancer Research Centre at Weston Park Hospital

Sheffield, England, S1O 2SJ, United Kingdom

Location

Aberdeen Royal Infirmary

Aberdeen, Scotland, AB25 2ZN, United Kingdom

Location

Edinburgh Cancer Centre at Western General Hospital

Edinburgh, Scotland, EH4 2XU, United Kingdom

Location

Western Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Gartnavel General Hospital

Glasgow, Scotland, G12 0YN, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 24618336 DERIVED

MeSH Terms

Conditions

Sarcoma; Hemangiosarcoma; Fibrosarcoma; Leiomyosarcoma; Liposarcoma; Rhabdomyosarcoma; Sarcoma, Synovial; Histiocytoma, Malignant Fibrous; Neurofibrosarcoma

Interventions

pegfilgrastim; Doxorubicin; Ifosfamide; Combined Modality Therapy

Condition Hierarchy (Ancestors)

Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Vascular Tissue; Neoplasms, Fibrous Tissue; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Neoplasms, Adipose Tissue; Myosarcoma; Histiocytoma; Neurofibroma; Nerve Sheath Neoplasms; Neoplasms, Nerve Tissue; Peripheral Nervous System Neoplasms; Nervous System Neoplasms; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

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; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Therapeutics

Study Officials

• Ian R. Judson, MA, MD, FRCP

  Institute of Cancer Research, United Kingdom

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2003
• First Posted: June 6, 2003
• Study Start: April 1, 2003
• Primary Completion: May 1, 2010
• Study Completion: July 1, 2012
• Last Updated: October 27, 2014

Record last verified: 2014-10

Locations

NL (5); FR (3); AU (1); CH (1); DK (2); GB (11); BE (3); ES (2); SL (1); CA (5); DE (7)