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Doxorubicin With or Without Ifosfamide and Pegfilgrastim in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), July 2009
First Received: June 5, 2003   Last Updated: July 22, 2009   History of Changes
Sponsor: European Organization for Research and Treatment of Cancer
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00061984
  Purpose

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.


Condition Intervention Phase
Sarcoma
 Biological: pegfilgrastim
Drug: doxorubicin hydrochloride
Drug: ifosfamide
Procedure: multimodality therapy
 Phase III

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control
Official Title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

Resource links provided by NLM:

MedlinePlus related topics: Cancer Soft Tissue Sarcoma
Drug Information available for: Doxorubicin Doxorubicin hydrochloride Myocet Pegfilgrastim Ifosfamide
U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response as assessed by RECIST criteria [ Designated as safety issue: No ]
  • Toxicity as assessed by CTC 2.0 [ Designated as safety issue: Yes ]
  • Treatment-related mortality [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: April 2003
Detailed Description:

OBJECTIVES:

  • 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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00061984

  Hide Study Locations
Locations
Austria
Karl-Franzens-University Graz Recruiting
Graz, Austria, A-8010
Contact: Contact Person     43-316-380-4100        
Belgium
Institut Jules Bordet Recruiting
Brussels, Belgium, 1000
Contact: Contact Person     32-2-541-3510        
U.Z. Gasthuisberg Recruiting
Leuven, Belgium, B-3000
Contact: Contact Person     32-16-332-211        
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, B-2650
Contact: Contact Person     32-3-821-3000        
Canada, Alberta
Cross Cancer Institute at University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 1Z2
Contact: Contact Person     780-432-8771        
Tom Baker Cancer Centre - Calgary Recruiting
Calgary, Alberta, Canada, T2N 4N2
Contact: Contact Person     403-521-3701        
Canada, Newfoundland and Labrador
Doctor H. Bliss Murphy Cancer Centre Recruiting
St. John's, Newfoundland and Labrador, Canada, A1B 3V6
Contact: Contact Person     709-777-7589        
Canada, Ontario
Margaret and Charles Juravinski Cancer Centre Recruiting
Hamilton, Ontario, Canada, L8V 5C2
Contact: Contact Person     905-387-9495        
Canada, Quebec
McGill Cancer Centre at McGill University Recruiting
Montreal, Quebec, Canada, H3G 1Y6
Contact: Contact Person     514-398-1444        
Denmark
Aarhus Universitetshospital - Aarhus Sygehus Recruiting
Aarhus, Denmark, DK-8000
Contact: Contact Person     45-89-49-3333        
Copenhagen County Herlev University Hospital Recruiting
Copenhagen, Denmark, DK-2730
Contact: Contact Person     45-44-88-3499        
France
Centre Leon Berard Recruiting
Lyon, France, 69373
Contact: Contact Person     33-04-78-782-645        
CHU de la Timone Recruiting
Marseille, France, 13385
Contact: Contact Person     33-91-385-708        
Institut Bergonie Recruiting
Bordeaux, France, 33076
Contact: Contact Person     33-556-333-333        
Germany
Klinikum der Stadt Mannheim Recruiting
Mannheim, Germany, D-68135
Contact: Contact Person     49-621-383-3833        
Universitaetsklinikum Essen Recruiting
Essen, Germany, D-45122
Contact: Contact Person     49-201-723-2321        
Medizinische Hochschule Hannover Recruiting
Hannover, Germany, D-30625
Contact: Contact Person     49-511-532-6710        
Medizinische Universitaetsklinik I at the University of Cologne Recruiting
Cologne, Germany, D-50924
Contact: Contact Person     49-221-478-4400        
Southwest German Cancer Center at Eberhard-Karls-University Recruiting
Tuebingen, Germany, D-72076
Contact: Contact Person     49-7071-292-711        
Klinikum der Universitaet Muenchen - Grosshadern Campus Recruiting
Munich, Germany, D-81377
Contact: Contact Person     49-89-7095-2550        
Universitatsklinikum Carl Gustav Carus Recruiting
Dresden, Germany, D-01307
Contact: Contact Person     49-351-458-3522        
Netherlands
Leiden University Medical Center Recruiting
Leiden, Netherlands, 2300 CA
Contact: Contact Person     31-71-526-9111        
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital Recruiting
Amsterdam, Netherlands, 1066 CX
Contact: Contact Person     31-20-512-9111        
Universitair Medisch Centrum St. Radboud - Nijmegen Recruiting
Nijmegen, Netherlands, NL-6500 HB
Contact: Contact Person     31-24-361-5215        
University Medical Center Groningen Recruiting
Groningen, Netherlands, 9700 RB
Contact: Contact Person     31-50-361-2317        
University Medical Center Rotterdam at Erasmus Medical Center Recruiting
Rotterdam, Netherlands, 3000 CA
Contact: Contact Person     31-10-463-9222        
Slovakia
National Cancer Institute - Bratislava Recruiting
Bratislava, Slovakia, 833 10
Contact: Contact Person     421-7-5937-8111        
Spain
Hospital Universitario San Carlos Recruiting
Madrid, Spain, 28040
Contact: Contact Person     34-91-543-3834        
Vall d'Hebron University Hospital Recruiting
Barcelona, Spain, 08035
Contact: Contact Person     34-93-274-6077        
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
Lausanne, Switzerland, CH-1011
Contact: Contact Person     41-21-314-0150        
United Kingdom, England
Cancer Research Centre at Weston Park Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2SJ
Contact: Contact Person     44-114-226-5000        
Derriford Hospital Recruiting
Plymouth, England, United Kingdom, PL6 8DH
Contact: Contact Person     44-175-277-7111        
Leeds Cancer Centre at St. James's University Hospital Recruiting
Leeds, England, United Kingdom, LS9 7TF
Contact: Contact Person     44-113-243-3144        
Northern Centre for Cancer Treatment at Newcastle General Hospital Recruiting
Newcastle-Upon-Tyne, England, United Kingdom, NE4 6BE
Contact: Contact Person     44-191-219-4200        
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Contact Person     44-121-472-1311        
Royal Marsden - London Recruiting
London, England, United Kingdom, SW3 6JJ
Contact: Contact Person     44-20-7352-8171        
University College of London Hospitals Recruiting
London, England, United Kingdom, WIT 3AA
Contact: Contact Person     44-20-7636-8333        
United Kingdom, Scotland
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Contact Person     44-1224-681-818        
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Contact Person     44-131-537-1000        
Gartnavel General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G12 0YN
Contact: Contact Person     44-141-211-3242        
Western Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Contact Person     44-141-211-2000        
Sponsors and Collaborators
European Organization for Research and Treatment of Cancer
Investigators
Investigator: Ian R. Judson, MA, MD, FRCP Institute of Cancer Research, United Kingdom
  More Information

Additional Information:
Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers: CDR0000302584, EORTC-62012
Study First Received: June 5, 2003
Last Updated: July 22, 2009
ClinicalTrials.gov Identifier: NCT00061984     History of Changes
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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

Additional relevant MeSH terms:
Neoplasms by Histologic Type
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antibiotics, Antineoplastic
Doxorubicin
Pharmacologic Actions
Neoplasms, Connective and Soft Tissue
 Neoplasms
Ifosfamide
Therapeutic Uses
Sarcoma
Antineoplastic Agents, Alkylating
Alkylating Agents
Isophosphamide mustard

ClinicalTrials.gov processed this record on November 27, 2009



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