National Cancer Institute National Cancer Institute
U.S. National Institutes of Health National Cancer Institute
In English | En español
NCI Home Cancer Topics Clinical Trials Cancer Statistics Research & Funding News About NCI
Clinical Trials (PDQ®)
Patient VersionHealth Professional Version
Last Modified: 7/21/2009     First Published: 5/23/2003  
Page Options
Print This Page  Print This Page
E-Mail This Document  E-Mail This Document
Clinical Trial Questions?
Get Help:

1-800-4-CANCER or

LiveHelp online chat

Quick Links
Help Using the NCI Clinical Trials Search Form

Educational Materials About Clinical Trials

About NCI's Cancer Clinical Trials Registry

Dictionary of Cancer Terms

NCI Drug Dictionary
Phase III Randomized Study of Doxorubicin With Versus Without Ifosfamide and Pegfilgrastim in Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIITreatmentActive18 to 60OtherEORTC-62012
NCT00061984

Objectives

  1. 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.
  2. Compare the response in patients treated with these regimens.
  3. Compare the treatment-related mortality of patients treated with these regimens.
  4. Compare the toxicity of these regimens in these patients.

Entry Criteria

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


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

Patient Characteristics:

Age

  • 18 to 60

Performance status

  • WHO 0-1

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count at least 2,000/mm3
  • Platelet count at least 100,000/mm3

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

Expected Enrollment

450

A total of 450 patients will be accrued for this study within 4 years.

Outcomes

Primary Outcome(s)

Overall survival

Secondary Outcome(s)

Response as assessed by RECIST criteria
Toxicity as assessed by CTC 2.0
Treatment-related mortality

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.

Trial Contact Information

Trial Lead Organizations

European Organization for Research and Treatment of Cancer

Ian Judson, MA, MD, FRCP, Study coordinator
Ph: 44-20-8722-4303

Trial Sites

Austria
  Graz
 Karl-Franzens-University Graz
 Contact Person
Ph: 43-316-380-4100
Belgium
  Brussels
 Institut Jules Bordet
 Contact Person
Ph: 32-2-541-3510
  Edegem
 Universitair Ziekenhuis Antwerpen
 Contact Person
Ph: 32-3-821-3000
  Leuven
 U.Z. Gasthuisberg
 Contact Person
Ph: 32-16-332-211
Canada
Alberta
  Calgary
 Tom Baker Cancer Centre - Calgary
 Contact Person
Ph: 403-521-3701
  Edmonton
 Cross Cancer Institute at University of Alberta
 Contact Person
Ph: 780-432-8771
Newfoundland and Labrador
  St. John's
 Doctor H. Bliss Murphy Cancer Centre
 Contact Person
Ph: 709-777-7589
Ontario
  Hamilton
 Margaret and Charles Juravinski Cancer Centre
 Contact Person
Ph: 905-387-9495
Quebec
  Montreal
 McGill Cancer Centre at McGill University
 Contact Person
Ph: 514-398-1444
Denmark
  Aarhus
 Aarhus Universitetshospital - Aarhus Sygehus
 Contact Person
Ph: 45-89-49-3333
  Copenhagen
 Copenhagen County Herlev University Hospital
 Contact Person
Ph: 45-44-88-3499
France
  Bordeaux
 Institut Bergonie
 Contact Person
Ph: 33-556-333-333
  Lyon
 Centre Leon Berard
 Contact Person
Ph: 33-04-78-782-645
  Marseille
 CHU de la Timone
 Contact Person
Ph: 33-91-385-708
Germany
  Cologne
 Medizinische Universitaetsklinik I at the University of Cologne
 Contact Person
Ph: 49-221-478-4400
  Dresden
 Universitatsklinikum Carl Gustav Carus
 Contact Person
Ph: 49-351-458-3522
  Essen
 Universitaetsklinikum Essen
 Contact Person
Ph: 49-201-723-2321
  Hannover
 Medizinische Hochschule Hannover
 Contact Person
Ph: 49-511-532-6710
  Mannheim
 Klinikum der Stadt Mannheim
 Contact Person
Ph: 49-621-383-3833
  Munich
 Klinikum der Universitaet Muenchen - Grosshadern Campus
 Contact Person
Ph: 49-89-7095-2550
  Tuebingen
 Southwest German Cancer Center at Eberhard-Karls-University
 Contact Person
Ph: 49-7071-292-711
Netherlands
  Amsterdam
 Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
 Contact Person
Ph: 31-20-512-9111
  Groningen
 University Medical Center Groningen
 Contact Person
Ph: 31-50-361-2317
  Leiden
 Leiden University Medical Center
 Contact Person
Ph: 31-71-526-9111
  Nijmegen
 Universitair Medisch Centrum St. Radboud - Nijmegen
 Contact Person
Ph: 31-24-361-5215
  Rotterdam
 University Medical Center Rotterdam at Erasmus Medical Center
 Contact Person
Ph: 31-10-463-9222
Slovakia
  Bratislava
 National Cancer Institute - Bratislava
 Contact Person
Ph: 421-7-5937-8111
Spain
  Barcelona
 Vall d'Hebron University Hospital
 Contact Person
Ph: 34-93-274-6077
  Madrid
 Hospital Universitario San Carlos
 Contact Person
Ph: 34-91-543-3834
Switzerland
  Lausanne
 Centre Hospitalier Universitaire Vaudois
 Contact Person
Ph: 41-21-314-0150
United Kingdom
England
  Birmingham
 Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
 Contact Person
Ph: 44-121-472-1311
  Leeds
 Leeds Cancer Centre at St. James's University Hospital
 Contact Person
Ph: 44-113-243-3144
  London
 Royal Marsden - London
 Contact Person
Ph: 44-20-7352-8171
 University College of London Hospitals
 Contact Person
Ph: 44-20-7636-8333
  Newcastle-Upon-Tyne
 Northern Centre for Cancer Treatment at Newcastle General Hospital
 Contact Person
Ph: 44-191-219-4200
  Plymouth
 Derriford Hospital
 Contact Person
Ph: 44-175-277-7111
  Sheffield
 Cancer Research Centre at Weston Park Hospital
 Contact Person
Ph: 44-114-226-5000
Scotland
  Aberdeen
 Aberdeen Royal Infirmary
 Contact Person
Ph: 44-1224-681-818
  Edinburgh
 Edinburgh Cancer Centre at Western General Hospital
 Contact Person
Ph: 44-131-537-1000
  Glasgow
 Gartnavel General Hospital
 Contact Person
Ph: 44-141-211-3242
 Western Infirmary
 Contact Person
Ph: 44-141-211-2000

Registry Information
Official Title Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma
Trial Start Date 2003-04-08
Registered in ClinicalTrials.gov NCT00061984
Date Submitted to PDQ 2003-04-15
Information Last Verified 2009-07-21

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

Back to TopBack to Top

A Service of the National Cancer Institute
Department of Health and Human Services National Institutes of Health USA.gov