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Brostallicin in Treating Patients With Locally Advanced or Metastatic Soft Tissue Sarcoma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00041249
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : July 18, 2012
Information provided by (Responsible Party):
European Organisation for Research and Treatment of Cancer - EORTC

Brief Summary:

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of brostallicin in treating patients who have locally advanced or metastatic soft tissue sarcoma that has not responded to one previous chemotherapy regimen.

Condition or disease Intervention/treatment Phase
Gastrointestinal Stromal Tumor Sarcoma Drug: brostallicin Phase 2

Detailed Description:


  • Determine the antitumor activity of brostallicin, in terms of objective response, in patients with locally advanced or metastatic soft tissue sarcoma who have failed one prior chemotherapy treatment.
  • Determine the time to progression and duration of response in patients treated with this drug.
  • Determine the safety and toxic effects of this drug in these patients.
  • Correlate clinical outcome with whole blood glutathione level in patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to tumor (tumors other than gastrointestinal stromal tumor (GIST) vs GIST).

Patients receive brostallicin IV over 10 minutes on day 1. Treatment repeats every 21 days for at least 4 courses in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months for 1 year and then every 4 months for 1 year.

PROJECTED ACCRUAL: A total of 58-72 patients (40 for stratum I and 18-32 for stratum II) will be accrued for this study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Primary Purpose: Treatment
Official Title: Efficacy And Safety Study Of Brostallicin In Patients With Locally Advanced Or Metastatic Soft Tissue Sarcoma Failing One Prior Chemotherapy Treatment
Study Start Date : May 2002
Actual Primary Completion Date : January 2004

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Histologically confirmed soft tissue sarcoma that is not amenable to surgery, radiotherapy, or combined modality therapy with curative intent
  • Stratum I

    • Malignant fibrous histiocytoma
    • Liposarcoma
    • Rhabdomyosarcoma
    • Synovial sarcoma
    • Malignant paraganglioma
    • Fibrosarcoma
    • Leiomyosarcoma
    • Angiosarcoma including hemangiopericytoma
    • Malignant peripheral nerve sheath tumor
    • Unclassified sarcoma
    • Miscellaneous sarcoma
  • Stratum II

    • Gastrointestinal stromal tumor
    • Previously treated with imatinib mesylate for locally advanced or metastatic disease and demonstrated disease progression
  • The following sarcoma types are excluded:

    • Mixed mesodermal tumors of the uterus (and carcinosarcoma)
    • Chondrosarcoma
    • Malignant mesothelioma
    • Neuroblastoma
    • Osteosarcoma
    • Ewing's sarcoma
    • Embryonal rhabdomyosarcoma
  • At least one measurable lesion
  • Progressive disease after 1 prior anthracycline- and/or alkylating-containing chemotherapy regimen for locally advanced or metastatic disease
  • Clinical evidence of progression within 6 weeks prior to study treatment
  • No known or symptomatic CNS metastases



  • Over 15

Performance status:

  • WHO 0-1

Life expectancy:

  • Not specified


  • WBC at least 4,000/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.25 times upper limit of normal (ULN)
  • SGPT and SGOT no greater than 3 times ULN
  • Alkaline phosphatase no greater than 2.5 times ULN


  • Creatinine no greater than 1.4 mg/dL OR
  • Creatinine clearance greater than 65 mL/min


  • No prior severe cardiovascular disease


  • Not pregnant
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 6 months after study
  • No other prior or concurrent malignancy except adequately treated basal cell skin cancer or carcinoma in situ of the cervix
  • No other severe medical illness
  • No psychosis


Biologic therapy:

  • No concurrent biologic response modifiers or immunotherapy
  • No concurrent prophylactic hematopoietic growth factors (e.g., filgrastim (G- CSF) or sargramostim (GM-CSF)


  • See Disease Characteristics
  • More than 4 weeks since prior chemotherapy and recovered
  • Prior adjuvant chemotherapy as first-line treatment allowed provided disease progressed within 6 months after the completion of chemotherapy
  • No prior ecteinascidin 743 (stratum I)
  • No other concurrent chemotherapy

Endocrine therapy:

  • No concurrent hormonal therapy


  • See Disease Characteristics
  • Recovered from prior radiotherapy
  • No prior radiotherapy to sole measurable lesion
  • Concurrent palliative radiotherapy to nontarget lesions allowed at investigator's discretion


  • See Disease Characteristics
  • Recovered from prior surgery


  • No other concurrent anticancer therapy (approved or investigational)
  • No concurrent participation in any other clinical treatment study
  • No other concurrent investigational drugs

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00041249

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Universitair Ziekenhuis Antwerpen
Edegem, Belgium, B-2650
U.Z. Gasthuisberg
Leuven, Belgium, B-3000
Centre Leon Berard
Lyon, France, 69008
CHU de la Timone
Marseille, France, 13385
Institut Gustave Roussy
Villejuif, France, F-94805
Robert Roessle Klinik
Berlin, Germany, D-13122
Universitaets-Krankenhaus Eppendorf
Hamburg, Germany, D-20246
Medizinische Hochschule Hannover
Hannover, Germany, D-30625
Klinikum Grosshadern der Ludwig-Maximilians Universitaet Muenchen
Munich, Germany, D-81377
Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital
Amsterdam, Netherlands, 1066 CX
Academisch Ziekenhuis Groningen
Groningen, Netherlands, 9700 RB
Leiden University Medical Center
Leiden, Netherlands, 2300 RC
Daniel Den Hoed Cancer Center at Erasmus University Medical Center
Rotterdam, Netherlands, 3008 AE
United Kingdom
St. James's University Hospital
Leeds, England, United Kingdom, LS9 7TF
Royal Marsden NHS Trust - London
London, England, United Kingdom, SW3 6JJ
Northern Centre for Cancer Treatment at Newcastle General Hospital
Newcastle Upon Tyne, England, United Kingdom, NE4 6BE
Sponsors and Collaborators
European Organisation for Research and Treatment of Cancer - EORTC
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Study Chair: Michael Leahy, MBChB, FRACP, FRCP, FRC Path Fremantle Hospital

Publications of Results:
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Responsible Party: European Organisation for Research and Treatment of Cancer - EORTC Identifier: NCT00041249     History of Changes
Other Study ID Numbers: EORTC-62011
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by European Organisation for Research and Treatment of Cancer - EORTC:
adult synovial sarcoma
adult angiosarcoma
adult fibrosarcoma
adult leiomyosarcoma
adult liposarcoma
adult neurofibrosarcoma
stage III adult soft tissue sarcoma
recurrent adult soft tissue sarcoma
adult malignant fibrous histiocytoma
adult malignant hemangiopericytoma
adult rhabdomyosarcoma
gastrointestinal stromal tumor
stage IV adult soft tissue sarcoma

Additional relevant MeSH terms:
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Gastrointestinal Stromal Tumors
Neoplasms, Connective and Soft Tissue
Neoplasms by Histologic Type
Neoplasms, Connective Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Digestive System Diseases
Gastrointestinal Diseases