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SarcomaPhase 3NCT00061984

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

A Phase 3 study testing pegfilgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 41 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Sarcoma
What is being tested?
pegfilgrastim, doxorubicin hydrochloride and ifosfamide
Type of treatment
Surgery or procedure
How many people
455 participants
Where
41 sitesin 11 countries
Study dates
Apr 2003to Jul 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

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

Trial locations and contacts

41 sites in 11 countries.

41 sites in 11 countries

United Kingdom11 sites

  • Aberdeen Royal Infirmary

    Aberdeen, Scotland, AB25 2ZN

  • Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust

    Birmingham, England, B15 2TH

  • Edinburgh Cancer Centre at Western General Hospital

    Edinburgh, Scotland, EH4 2XU

  • Western Infirmary

    Glasgow, Scotland, G11 6NT

  • Gartnavel General Hospital

    Glasgow, Scotland, G12 0YN

  • Leeds Cancer Centre at St. James's University Hospital

    Leeds, England, LS9 7TF

  • Royal Marsden - London

    London, England, SW3 6JJ

  • University College of London Hospitals

    London, England, WIT 3AA

  • Northern Centre for Cancer Treatment at Newcastle General Hospital

    Newcastle upon Tyne, England, NE4 6BE

  • Derriford Hospital

    Plymouth, England, PL6 8DH

  • Cancer Research Centre at Weston Park Hospital

    Sheffield, England, S1O 2SJ

Other trials in United Kingdom

Germany7 sites

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Universitatsklinikum Carl Gustav Carus

    Dresden, D-01307

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Medizinische Hochschule Hannover

    Hanover, D-30625

  • Klinikum der Stadt Mannheim

    Mannheim, D-68135

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Southwest German Cancer Center at Eberhard-Karls-University

    Tübingen, D-72076

Other trials in Germany

Canada5 sites

  • Tom Baker Cancer Centre - Calgary

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute at University of Alberta

    Edmonton, Alberta, T6G 1Z2

  • Margaret and Charles Juravinski Cancer Centre

    Hamilton, Ontario, L8V 5C2

  • McGill Cancer Centre at McGill University

    Montreal, Quebec, H3G 1Y6

  • Doctor H. Bliss Murphy Cancer Centre

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

Other trials in Canada

Netherlands5 sites

  • Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital

    Amsterdam, 1066 CX

  • University Medical Center Groningen

    Groningen, 9700 RB

  • Leiden University Medical Center

    Leiden, 2300 CA

  • Universitair Medisch Centrum St. Radboud - Nijmegen

    Nijmegen, NL-6500 HB

  • University Medical Center Rotterdam at Erasmus Medical Center

    Rotterdam, 3000 CA

Other trials in Netherlands

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1000

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

Other trials in Belgium

France3 sites

  • Institut Bergonie

    Bordeaux, 33076

  • Centre Leon Berard

    Lyon, 69373

  • CHU de la Timone

    Marseille, 13385

Other trials in France

Denmark2 sites

  • Aarhus Universitetshospital - Aarhus Sygehus

    Aarhus, DK-8000

  • Copenhagen County Herlev University Hospital

    Copenhagen, DK-2730

Other trials in Denmark

Spain2 sites

  • Vall d'Hebron University Hospital

    Barcelona, 08035

  • Hospital Universitario San Carlos

    Madrid, 28040

Other trials in Spain

Austria1 site

  • Karl-Franzens-University Graz

    Graz, A-8010

Other trials in Austria

Slovakia1 site

  • National Cancer Institute - Bratislava

    Bratislava, 833 10

Other trials in Slovakia

Switzerland1 site

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

Other trials in Switzerland

About this study

Official title: Randomised Trial Of Single Agent Doxorubicin Versus Doxorubicin Plus Ifosfamide In The First Line Treatment Of Advanced Or Metastatic Soft Tissue Sarcoma

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.

Read the 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.

Conditions
Sarcoma
Being tested
pegfilgrastim, doxorubicin hydrochloride, ifosfamide, multimodality therapy
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
Medical subject headings
Sarcoma, Hemangiosarcoma, Fibrosarcoma, Leiomyosarcoma, Liposarcoma, Rhabdomyosarcoma, Sarcoma, Synovial, Histiocytoma, Malignant Fibrous

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall survival

Secondary outcomes (3)

  1. Response as assessed by RECIST criteria

  2. Toxicity as assessed by CTC 2.0

  3. Treatment-related mortality

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Jun 2003 (estimated)
  2. Study startApr 2003
  3. Primary completionMay 2010
  4. Study completionJul 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Masking
None (open label)
Enrolment
455 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00061984
Sponsor's protocol ID
EORTC-62012
Other IDs
EORTC-62012
Status last verified
Oct 2014
First submitted
5 Jun 2003
Last updated
27 Oct 2014
Results posted
No

Publications

  • 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.

    PubMed 24618336

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing pegfilgrastim, doxorubicin hydrochloride and ifosfamide in people with Sarcoma, run by European Organisation for Research and Treatment of Cancer - EORTC at 41 sites in 11 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 41 sites in United Kingdom, Germany, Canada, Netherlands, Belgium and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Overall survival. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00061984, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2014.

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